Medical device recalls for September 2012

Class I recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage:The PVP contained in the kit is used in skin prep                The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP PrepProduct Usage: Usage:The PVP contained in the kit is used in skin prep         The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep             The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep             The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep             The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep            The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep             The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-4873 Custom CT Biopsy Tray; CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep  The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep      The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep              The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-20-2012       Povidine-Iodine prep solution/Providine prep pads – CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep SolutionProduct Usage: Usage:The PVP contained in the kit is used in skin prep         The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.

Class II recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Cook Ireland Ltd.              Sep-01-2012       Zilver 518 Vascular Self Expanding Stent – Zilver 518 Vascular Self Expanding StentThe Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.              Cook Ireland received a product complaint from Japan on December 22nd; 2011.  The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub.  After further examination; the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35

Exactech; Inc.    Sep-04-2012       OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED – OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW; 11mm; Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011.There are three product sizes being recalled; 11mm; 13mm; 15mm. All other information is the same.The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis; osteonecrosis; rheumatoid arthritis; and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.           Exactech; Inc. of Gainesville; FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert; Size 6 after the device was determined to be out of dimensional specification.

Trumpf Medical Systems; Inc.    Sep-05-2012       Acrobat 3000 (AC3000) Spring Arm – Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights; TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim.The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.                Cracks can arise on the welded seam on the rear joint.

Capintec Inc       Sep-05-2012       Capintec Captus 3000 Thyroid Uptake System – Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures; which consist of the measurement of organ uptake and circulating radioactivity.      Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22; 1.23; 1.24; 1.25; and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual."  This protocol was a new feature added to Software Revision 1.22 in January 2011.  The error occurs only if the user does NOT measure the residual dose immediately after me

RAYSEARCH LABORATORIES AB Sep-06-2012       Radiation Therapy Treatment Planning System – Brand name:  RayStation.  Generic name: Treatment Planning System.  Software version and build numbers are 2.5.0.144 and 2.5.1.89.  Product lifetime is 5 years.RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment; and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.          The firm decided to recall when an issue was found with the dose calculation in RayStation 2.5; Raystation 2.5.1. The problem has not caused any patient mistreatment or other incidents. However; the user must be aware of this information to avoid incorrect dose calculations during treatment planning. The dose calculation is not correctly normalized in the unusual case of preventing the optimizatio

Quality Electrodynamics LLC        Sep-06-2012       TxRx Knee 15 Coil 3T – TxRx Knee 15 Coil 3T.For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. On July 27; 2012; it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

Siemens Healthcare Diagnostics; Inc        Sep-06-2012       Siemens ADVIA Centaur Multi-Diluent 1 – Siemens ADVIA Centaur Multi-Diluent 1 – Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313).Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board the ADVIA Centaur and ADVIA Centaur XP systems for  for BNP and TSH3 Ultra assays

Breg Inc; An Orthofix Company Sep-06-2012       INTELLI-FLO DRESSING – Polar Dressing; Knee/MU/Shldr Intelli-Flo-Breg; PN 10630Used with cold therapy pads to provide insulation barrier between the pad and patient’s skin.       This recall has been initiated due to confirmation that the Polar Dressing; Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressingthinner; less durable and subject to tearing. The product is mislabeled.

AmeriWater Inc                Sep-06-2012       AmeriWater MRO Dialysis RO+ System – AmeriWater MRO Dialysis RO+ System; AmeriWater 1303 Stanley Avenue; Dayton; OH 45404 (800) 535-5585 www.AMERIWATER.com.The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital; clinic; dialysis center; or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital; clinic; or dialysis centers.            The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses; that was installed in the water system.  The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate.

Siemens Medical Solutions USA; Inc        Sep-06-2012       Siemens Mobilett Mira – Siemens Mobilett Mira.Mobile X-Ray System.                During regular product monitoring; Siemens has become aware of a potential issue with the Mobilett Mira system.  During normal clinical operation the switch on the motor drive handle of the unit may become loose and slide horizontally to the right and become trapped under the cover.  This may cause the system to continuously move.  In response; Siemens has issued Update Instruction XP038/12/S to r

Toshiba American Medical Systems Inc  Sep-06-2012       Toshiba Ultra-Short Magnetic Resonance Imaging System – Toshiba Ultra-Short Magnetic Resonance Imaging System; EXCELART Vantage. MRT-1503/P5-Vantage MRI System.MR imaging. The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.

Becton Dickinson & Co. Sep-06-2012       BD GeneOhm Cdiff Assay – BD GeneOhm Cdiff Assay ; Catalog # 441401; 200 box tests   2-3 labeled  in part***GeneOhm Sciences Canada; Inc.; 2555 boul; du Parc-Technologique; Quebec; QC; Canada G1P 4S5***BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test; based on real-time PCR; is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen; utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.      Leakage in Cepheid SmartCycler reaction tubes.

Becton Dickinson & Co. Sep-06-2012       BD GeneOhm" Cdiff Assay – BD GeneOhm Cdiff Assay ; Catalog #441400 200; box tests 1-3 labeled in part***BD Diagnostics; 2555 boul; du Parc-Technologique; Quebec; QC; Canada G1P 4S5***BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test; based on real-time PCR; is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen; utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.      Leakage in Cepheid SmartCycler reaction tubes.

Becton Dickinson & Co. Sep-06-2012       BD GeneOhm MRSA ACP Assay – BD GeneOhm MRSA ACP Assay; Catalog #441639; box 200 tests labeled in part***GeneOhm Sciences Canada; Inc. 2555 Boul; du Parc-Technologique; Quebec; QC; Canada G1P 4S5***BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .              Leakage in Cepheid SmartCycler reaction tubes.

Becton Dickinson & Co. Sep-06-2012       BD GeneOhm MRSA ACP Assay – BD GeneOhm MRSA ACP Assay Catalog #441637; box 48 tests labeled in part***GeneOhm Sciences Canada; Inc.; 2555 boul; du Parc-Technologique; Quebec; QC; Canada G1P 4S5***BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.                Leakage in Cepheid SmartCycler reaction tubes.

Becton Dickinson & Co. Sep-06-2012       BD GeneOhm VanR Assay – BD GeneOhm VanR Assay ; Catalog # 441250; 5 box tests  labeled in part***GeneOhm Sciences Canada; Inc.; 2555 boul; du Parc-Technologique; Quebec; QC; Canada G1P 4S5***.The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify; prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing; susceptibility testing and for further confirmatory identification.               Leakage in Cepheid SmartCycler reaction tubes.

Custom Medical Specialties; Inc.               Sep-07-2012       PVP Prep Solution – CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep SolutionThe PV contained in the kit is used in skin prep    The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-07-2012       PVP Prep Solution – CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep SolutionCMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution             The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Custom Medical Specialties; Inc.               Sep-07-2012       PVP Prep Solution – CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep SolutionThe PV contained in the kit is used in skin prep              The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

C.R. Bard; Inc.; Urological Division             Sep-07-2012       Bard Foley procedural trays packaged in breather bags – Bard Foley procedural trays packaged in breather bags.  The product is packaged ten units in each shipper box; and are sold sterile for single use.Used to catheterize patients. The finished trays are sold in Tyvek breather bags.         Incomplete seal on sterile packages of product.

Aesculap Implant Systems LLC   Sep-07-2012       Aesculap S4 Element 4.5mm Polyaxial Screws – Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T; ST241T; ST242T; ST243T; ST244T; and ST245T).The S4 Spinal System is intended for anterior/anterolateral and posterior; non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 – degenerative disc disease; 2 – spondylolisthesis; 3 – trauma; 4 – spinal stenosis; 5 – deformities or curvatures; 6 – tumor; 7 – pseudoarthrosis; and 8 – failed previous fusion.                There is a possibility that the screw channel that holds the rod in place may be out of tolerance.  When the depth of the channel is not deep enough; the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.

Custom Medical Specialties; Inc.               Sep-07-2012       PVP Prep Pad – CMS-2890 Custom Needle Local Tray containing PVP Prep PadThe PV contained in the kit is used in skin prep                The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.

Sunquest Information Systems; Inc.        Sep-07-2012       Sunquest Laboratory – Sunquest LaboratorySunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels; which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes; including: " Patient registration " Order entry and order modification " Specimen collection; verification; suitability; and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients; specimens; and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.              Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139; 6.2.1; 6.2.2; 7.0; and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used; a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge.  This occurs because a trigger from the Laboratory system for the event

Steris Corporation           Sep-07-2012       The SYSTEM 1E Liquid Sterilant Processing System. – The SYSTEM 1E Liquid Sterilant Processing System.The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices; including endoscopes and their accessories.    The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.

JK Products & Services; Inc          Sep-07-2012       SUN|DASH RADIUS 252 – SUN|DASH RADIUS 252 tanning system; 52 lamps; Ultraviolet Radiation.The device is intended to be used for tanning of the human skin.   The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line.  In some instances when the door cord is installed with little or no slack outside the upper decor piece; the cord has been known to fail causing a short in the wiring at the pivot point in the cord.

Siemens Medical Solutions USA; Inc        Sep-10-2012       Siemens Uroskop Access – Siemens Uroskop Access.Fluoroscopic; image intensified x-ray system  Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076.  When tilting the table on the Uroskop Access table; the motor may become disconnected and the entire table assembly may fall on the floor.

Volcano Corporation      Sep-10-2012       Volcano brand Intravascular Ultrasound – Volcano brand Intravascular Ultrasound; Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2; Models/Part Numbers: 435-0607.01; 435-0607.04; 435-0602.01; 435-0602.02; Product is manufactured and distributed by Volcano Corporation; Rancho Cordova; CA.Medical device for use in imaging of histology.      The display on the system has the potential to change. In house testing eventually identified the unique sequence of events that must occur in order for this issue to manifest itself.

Intuitive Surgical; Inc.     Sep-10-2012       Tip Cover; Accessory – Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory; Disposable; 8mm MCS; Box of 10.The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue; including: cutting; blunt and sharp dissection; electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci; da Vinci S and da Vinci Si Surgical Systems Models IS1200; 12000; ISSOQO).      There is potential for the sterility of the product to be compromised.

Medtronic Xomed; Inc. Sep-10-2012       NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces [Pulse;Response;Neuro] – Interfaces subject to recall:  Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse).LABELING:  Box Label:  REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed; Inc.; 6743 Southpoint Drive North Jacksonville; FL 32216-0980 USA***Rx Only***Lot***SN:***"Top of unit is labeled in part:  "***NIM-Response 3.0***Medtronic***"  Bottom/Underside of unit is labeled in part:  "***5X20mm FA.L.; 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE; FL USA***"  Cord is labeled in part:  "***Ref.***Mfg Date***Sn***"The NIM 3.0 Patient Interfaces [REF #’s 8253210 (Pulse); 8253200 (Response); 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery; including spinal cord and spinal nerve roots.         In January 2010; Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode).  When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel); it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu

Medtronic Xomed; Inc. Sep-10-2012       NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces [Pulse;Response;Neuro] – Interfaces subject to recall:  Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response)LABELING:  Box Label:  REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed; Inc.; 6743 Southpoint Drive North Jacksonville; FL 32216-0980 USA***Rx Only***Lot***SN:***"Top of unit is labeled in part:  "***NIM-Response 3.0***Medtronic***"  Bottom/Underside of unit is labeled in part:  "***5X20mm FA.L.; 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE; FL USA***"  Cord is labeled in part:  "***Ref.***Mfg Date***Sn***"The NIM 3.0 Patient Interfaces [REF #’s 8253210 (Pulse); 8253200 (Response); 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery; including spinal cord and spinal nerve roots.         In January 2010; Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode).  When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel); it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu

Medtronic Xomed; Inc. Sep-10-2012       NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces [Pulse;Response;Neuro] – Interfaces subject to recall:  Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro).LABELING:  Box Label:  REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed; Inc.; 6743 Southpoint Drive North Jacksonville; FL 32216-0980 USA***Rx Only***Lot***SN:***"Top of unit is labeled in part:  "***NIM-Response 3.0***Medtronic***"  Bottom/Underside of unit is labeled in part:  "***5X20mm FA.L.; 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE; FL USA***"  Cord is labeled in part:  "***Ref.***Mfg Date***Sn***"The NIM 3.0 Patient Interfaces [REF #’s 8253210 (Pulse); 8253200 (Response); 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery; including spinal cord and spinal nerve roots.         In January 2010; Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode).  When the NIM 3.0 detects the signal loss from the electrode (i.e. open channel); it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu

Philips Healthcare Inc.    Sep-10-2012       Philips HeartStart MRx monitor/defibrillators – Philips HeartStart MRx monitor/defibrillatorsModels: M3535A and M3536A; M3536J; M3536M; M3536MC; M3536M1; M3536M2; M3536M3; M3536M4; M3536M5; M3536M6The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support; advanced cardiac support; or defibrillation. It must be used by or on the order of a physician                Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables

Hospira; Inc.       Sep-10-2012       Sterile Empty Vial and Injector (30mL PCA vial); – Sterile Empty Vial and Injector (30mL PCA vial); Rx only; One/List No. 6021-03; Hospira; Inc.; Lake Forest; IL 60045.For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device. Reports of leaking during filling and administration.

Elekta; Inc.          Sep-10-2012       Agility – Multileaf CollimatorTo be used for single or multiple fractions; delivered as static and/or dynamic beams of radiation; in all areas of the body where such treatment is indicated. Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.

Terumo Cardiovascular Systems Corporation      Sep-11-2012       Sarns System 8000 – Safety monitor included with System 8000 BaseThe Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit; and to stop the arterial and cardioplegia pumps.                Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate; TerumoDubai that the safety monitors were tripping off. Terumo CVS’ investigation determined that 8monitors were manufactured with an underrated circuit breaker due to an error where an associatepulled an underrated circuit breaker from an incorrect inventory location. Since this time; inventorylocations hav

Lucero Medical LLC          Sep-11-2012       Enduramesh Corpectomy Spacer System – Enduramesh Corpectomy Spacer SystemProduct Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed; damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.     The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm; DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm; DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm; DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm; DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm; DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Exactech; Inc.    Sep-11-2012       NOVATION MODULAR DRILL BIT – REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm; DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court; Gainesville; FL 32653***.To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically; these instruments are reusable; surgically invasive; and intended for transient use.             Exactech Inc. of Gainesville; FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.

Siemens Medical Solutions USA; Inc        Sep-11-2012       Siemens Mobilett Mira – Siemens Mobilett Mira mobile x-ray systemProduct Usage:Mobile x-ray system         During regular product monitoring; firm became aware of a potential issue with the Mobilett Mira system; (serial numbers 1034; 1038; 1041; 1042; 1043; 1050; 1053; and 1054.  During normal clinical operation the center screw on the driving wheel may become loose resulting in system immobilization.  There is no risk of the system tipping over or collapsing on the floor; however the system may tilt t

Biosense Webster; Inc. Sep-12-2012       CARTO 3 V1.05 System – CARTO 3 V1.05(FG-5400-00).The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps; cardiac electrical propagation maps; cardiac electrical potential maps; impedance maps and cardiac chamber geometry maps. The acquired patient signals; including body surface ECG and intracardiac electrograms may also be displayed in real time on the System’s display screen. The CARTO 3 V1.05 System is also intended to support EP procedures; maintaining CARTO¿ XP System capabilities; in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import; register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation; the Fast Anatomical Mapping (FAM) functionality; enabling creation of cardiac maps using’catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality; that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters; the system is also intended for use with non-navigational electrophysiology catheters.            The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment; including the CARTO 3 Electropysiology Mapping System.

Capsule Tech Inc.             Sep-13-2012       Capsule Neuron Docking Station – Capsule Neuron Docking Station; a component in the DataCaptor Connectivity SystemCatalog Number DC-NU-DS-CKThe Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron UMPC which is a bedside device that enables automatic collection of vital signs data that can connect to the hospital network through a wired Ethernet connection or via a standard 802.11 b/g/n wireless network.                Capsule Neuron Docking Station may experience a lost connection; resulting in loss of data or loss of power to the Caspsule Neuron

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 1 x 4mmRef: KC-54010.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 2 x 4mmRef: KC-54020.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

GE Healthcare; LLC          Sep-13-2012       Optima – Optima XR200amx.  Mobile general purpose radiographic imaging of the human head and body. Software issue: a violation of 21 CFR 1020.31(a).  After an image is taken; when the user selects and clears an additionally displayed screen the system inhibit is also cleared; allowing the user to take an exposure without the technique factors being displayed.

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 4 x 4mmRef: KC-54040.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 5 x 4mmRef: KC-54050.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 6 x 4mmRef: KC-54060.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

GE Healthcare; LLC          Sep-13-2012       Optima – Optima XR220amx    Mobile general purpose radiographic imaging of the human head and body. Software issue: a violation of 21 CFR 1020.31(a).  After an image is taken; when the user selects and clears an additionally displayed screen the system inhibit is also cleared; allowing the user to take an exposure without the technique factors being displayed.

GE Healthcare; LLC          Sep-13-2012       GE Healthcare; Innova 2121IQ; Innova 3131IQ Cardiovascular X-ray imaging systems. – GE Healthcare; Innova 2121IQ; Innova 3131IQ Cardiovascular X-ray imaging systems.K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology; diagnostic; and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ; Innova 3131IQ; Innova 4100; Innova 4100IQ; Innova 3100; Innova 3100IQ; Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology; diagnostic; and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name; date of birth; DICOM attributes etc.) from Innova system with an IVUS imaging system; (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface; (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography; diagnostic and interventional procedures; and optionally; rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology; diagnostic; and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.            GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems; there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.

Omni Life Science            Sep-13-2012       Omnilife Science Apex Knee System Modular Tibia Augment – Omnilife Science Apex Knee System Modular Tibia Augment; Size 3 x 4mmRef: KC-54030.The Apex Knee System is intended for use as a primary or revision total knee replacement.        The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches; compromising the sterility

Zoe Medical Incorporated            Sep-14-2012       Ultraview DM3 Monitor – Spacelabs Ultraview DM3 MonitorModel Number: 91330-NTThe Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring; recording; and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2; pulse rate; NIBP; and temperature.            Unit fails to power up; resulting in an equipment alarm

Tedan Surgical Innovations Llc    Sep-14-2012       Sterile Distraction Screws of 3 different sizes – Sterile Distraction Screws of 3 different sizes:  12mm; 14mm and 16mm sold under TSI; 3COR; DB Surgical; and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm; 100mm; 110mm; 120mm; 130mm; 140mm; 150mm sold under TSI brandSterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.    This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube.  Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.

Varian Medical Systems; Inc. Oncology Systems                Sep-14-2012       Varian brand Clinac; Trilogy; Novalis Tx Unique; linear accelerators – Varian brand Clinac; Trilogy; Novalis Tx; Unique; linear accelerators; Model Number: H14; H18; H29;  Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA.1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment is indicated.               Some X-jaws (lower collimator jaw) carriers were manufactured with the incorrect metal alloy; which can potentially cause the jaw carrier to crack. If both jaw carriers on the same X-jaw were to crack; the jaw would be able to move freely in the closed direction.  In this case; the deviation of the jaw position will not be detected by the position readout interlock circuitry; Treatment after such

Philips Medical Systems (Cleveland) Inc Sep-14-2012       MX 16-slice – MX 16-slice CT Scanner System; models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system. On August 24; 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail; resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

RAYSEARCH LABORATORIES AB Sep-14-2012       RayAutoplan; aka t-RayAutoplan; commercial name (TomoTherapy) SharePlan – The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected; bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10.Intended use: t-RayAutoplan is a software that; based on the planned dose distribution from a TomoPlan treatment planning system; generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans; the user selects and clinically approves a treatment plan and exports it electronically to DICOM; for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff; such as medical physicists; medical doctors or dosimetrists     This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However; the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere

Integra Life Sci. Sep-14-2012       Integra 2.7 mm Drilling Guide – The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis; Uni-CP; Advansys MLP and Advansys DLP compression plate systems.The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis; Uni-CP; Advansys MLP and Advansys DLP systems.  Should the Drilling Guides need to be replaced; they can be replenished by the customer placing an order.  The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: – Arthrodesis in foot and ankle surgery – Fracture management in the foot and ankle – Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint; distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures; fusions; osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: – Lisfranc arthrodesis – Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint               Integra’ s quality system noted an adverse trend in complaints for breakage of the drilling guides during use.  None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure.  A physician was consulted to assess patient risk and concluded that any potential for risk would be transient; self-limiting or minor; or result

Covidien LLC       Sep-14-2012       HALO Flex Energy Generators – HALO Flex Energy GeneratorsManufactured by B¿RRX Medical (now Covidien)540 Oakmead ParkwaySunnyvale; CA 95085.The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to; the esophagus; including Barrett’s Esophagus.                Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

Instrumentation Laboratory Co.                Sep-14-2012       "Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP 500 CTS               PN 0000280040 ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters" Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Instrumentation Laboratory Co.                Sep-14-2012       "Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP 700 CTS               PN 0000280050 ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters" Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Instrumentation Laboratory Co.                Sep-14-2012       Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP CTSPN 0000280020 ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters        Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Instrumentation Laboratory Co.                Sep-14-2012       Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP 700PN 0000280010ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters        Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Spacelabs Healthcare; Llc              Sep-14-2012       Integrated Module Housing – Ultraview SL 91493 Integrated Module Housing.PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high; medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices; network devices; serial devices; user input devices; audio system; local/remote recorders and Spacelabs Medical patient parameter modules. In all applications; Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network; a patient’s data may be displayed at the bedside monitor; central station or clinical information system.          There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.

Instrumentation Laboratory Co.                Sep-14-2012       Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP (Base)PN 0000280000ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters        Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Philips Healthcare Inc.    Sep-14-2012       Philips DigitalDiagnost Systems – Philips DigitalDiagnost Systems with M Cabinet Model: 712025Stationary radiographic system; digital-Universal RAD Applications              Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC)  International standard of 5.5 mm.

Instrumentation Laboratory Co.                Sep-14-2012       "Automated Coagulation Analyzer – Instrumentation Laboratory ACL TOP 700 LAS               PN 0000280030 ACL TOP is a bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters" Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Bio-Rad Laboratories      Sep-17-2012       MONOLISA ANTI-HBs EIA – The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220.  It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma.  The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.  Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Vascular Solutions; Inc.  Sep-17-2012       Guardian II NC Hemostasis Valve with Guidewire Introducer – Guardian II Hemostasis Valve; Model 8210 and Guardian II NC Hemostasis Valve; Model FH102.Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.       Vascular Solutions; Inc.; became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.

Biomet; Inc.        Sep-17-2012       Biomet Juggerknot in Guide Punch – JUGGERKNOT IN¿GUIDE PUNCH; 2.9MM.The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.    Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet; causing the knob to potentially unfasten and slide down the shaft.

BD Biosciences; Systems & Reagents      Sep-17-2012       BD FACS 7-color Setup Beads – BD FACS 7-color Setup beadsBD Biosciences; San Jose; CA 95131.BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup; including automated compensation and cytometer quality control (QC) with minimal user intervention.  Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

ZOLL Medical Corporation            Sep-17-2012       Zoll Medical – Zoll X Series Defibrillator/Pacemaker/MonitorProduct Usage:The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition; the product may be used in synchronized mode to terminate certain atrial and ventricular tachycardias and other arrhythmias resistant to drug therapy. The X Series may be used for cardiac pacing in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The X Series may be used for the monitoring a patients electrocardiogram (ECG).             Shipped with incorrect software

US Endoscopy Group Inc              Sep-17-2012       Infinity¿ sampling device; Cytology Brush – Infinity¿ sampling device; Cytology Brush; United States Endoscopy Group; Inc.; 5976 Heisley Road; Mentor; OH 44060The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.  US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

Steris Corporation           Sep-17-2012       Amsco 3085SP Surgical Table – A mobile; electro-hydraulically operated; fluoroscopic/C-Arm compatible general surgical table.  Product Usage:Product provides a flexible; easy-to-use; articulated posturing of a patient for either general; I.A.; or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.                Customers may be storing objects on the base and/or around the column of the surgical table.  This prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover.  Depending upon the nature and severity of the damage to the electronics of the table; it is possible that the table could move without prompting by an operator .

Hospira Inc.        Sep-17-2012       Empty Evacuated Container 250 mL and 1000 mL. – Empty Evacuated Container 250 mL and 1000 mL.Empty Evacuated containers are used for mixing compatible medications or blood collections.  Embedded iron oxide glass defect which may have the potential to break off into the solution.

Roche Molecular Systems; Inc.  Sep-18-2012       Amplilink Software v3.2 – Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR; CAP/CA; COBAS TaqMan;and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.      When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.

Elekta; Inc.          Sep-19-2012       Precise Digital Accelerator – Precise Digital AcceleratorDelivery of radiation to defined target volumes               There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose; leading to fatigue failure of some of the securing bolts.

DePuy Orthopaedics; Inc.             Sep-20-2012       S-Rom¿ Total Hip System Poly Liner – S-Rom¿ Total Hip System Poly LinerPackaging:   The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed.  This is then placed into a folding carton; labeled; and shrink-wrapped.Description: Total Hip System Poly Dial¿ Liner is part of the S-ROM¿ Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-ROM¿ stem. The S-ROM liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Intended Use: Total Hip System Poly Dial Liner is part of the S-Rom Total Hip System. The Liner is fitted inside the acetabular shell; and is the bearing surface for the Head on the S-Rom¿ stem. The S Rom liner is used for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.                Orthopaedics; Inc.  (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation.  We have received one complaint regarding this issue.

Integra LifeSciences Corporation              Sep-20-2012       CRW Precision Arc (CRWPRECISE); CRW Arc System (CRWASL) – Integra CRW Precision Arc (CRWPRECISE); CRW Arc System (CRWASL); HRAIM Head Ring Assembly with Intubation  MountsThe CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes              T-handle screw is used on a complementary product to the CRW; the Integra HRAIM; which is the CT-compatible intubation Head Ring Assembly.  When the T-handle on the HRAIM intubation hoop is tightened; the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated

Steris Corporation           Sep-20-2012       Surgical Tables – STERIS 5085 and 5085 SRT Surgical Tables; Product Usage:The 5085 is a general surgical table with high patient weight capacity; extended width capability; and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to; cardiac and vascular; endoscopic; gynecology; urology; nephrectomy; neurology; ophthalmologic; orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).        STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe; the up/down movement of the table may be impeded.  In addition; the table hand control may indicate that the table floor locks are unlock

Integra LifeSciences Corporation              Sep-20-2012       Head Ring Assembly with Intubation  Mounts (HRAIM) – Integra HRAIM Head Ring Assembly with Intubation  MountsThe CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes       T-handle screw is used on a complementary product to the CRW; the Integra HRAIM; which is the CT-compatible intubation Head Ring Assembly.  When the T-handle on the HRAIM intubation hoop is tightened; the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated

Smith & Nephew Inc      Sep-20-2012       12/14 TAPER HIGH OFFSET NECK – 12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR; REF 71352112; Smith & Nephew; Inc. Memphis; TN 38116 USA.USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.     Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

Sekisui Diagnostics Llc    Sep-20-2012       Spectrolyse PAI-1 – Sekisui Spectrolyse PAI-1; In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.       SPECTROLYSE PAI-1 activity assay  producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 15 LX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 15 LX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Davol; Inc.; Subs. C. R. Bard; Inc.                Sep-20-2012       Bard Ventralight ST Mesh – Bard Ventralight ST Mesh. – Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh; Surgical; Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies; such as for the repair of hernias.          Mislabeled:  The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10"  VENTRALIGHT ST Mesh product

Davol; Inc.; Subs. C. R. Bard; Inc.                Sep-20-2012       Bard Ventralight ST Mesh – Bard Ventralight ST Mesh. – Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh; Surgical; Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies; such as for the repair of hernias.          Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 18 LX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 18 LX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Steris Corporation           Sep-20-2012       Verify¿ Bowie-Dick Test Card – Verify¿ Bowie-Dick Test Card; Model #S3098; Steris Biological Operations; 9325 Pinecone Drive; Mentor; OH 44060The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card; space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has two holes in it to allow air removal and steam penetration. The preassembled test is used to evaluate the effectiveness of air removal from the sterilizer chamber during prevacuum pulse steam sterilizer cycle. Following a prevacuum cycle; the chemical bars of the Bowie-Dick Test card uniformly darken indicating that residual air has been sufficiently removed to allow complete steam penetration into the test card. If air is trapped in the card during the exposure phase of the cycle; the color change of the bars will be incomplete or uneven. Thus the card can provide an immediate indication of inadequate removal of air during a cycle. The Bowie-Dick Type test is performed in an empty chamber each day the sterilizer is to be used; usually before the first sterilization cycle.   STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications.  Specifically; test cards have resulted in false fail results when sterilizer performance is within acceptable ranges.

Kimberly-Clark Corporation         Sep-20-2012       Kimberly-Clark MIC Safety PEG Kit – Pull Type – Kimberly-Clark MIC Safety PEG Kit – Pull TypeThe Kimberly-Clark MIC PEG Kits – Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.                The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

Kimberly-Clark Corporation         Sep-20-2012       Kimberly-Clark MIC PEG Kit – Pull Type – Kimberly-Clark MIC PEG Kit – Pull TypeThe Kimberly-Clark MIC PEG Kits – Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.       The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 18 SX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 18 SX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 21 SX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 21 SX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 25 SX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 25 SX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 13 LX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 13 LX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Haag-Streit USA Inc         Sep-20-2012       Octopus 101 Perimeter – Octopus 101 Perimeter; PeriTrend Software AnalysisA perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface; and the patient indicates whether he or she sees the light.             The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101.

Asahi Kasei Medical Co.; Ltd.; Okatomi Plant        Sep-20-2012       Asahi KASEI; REXEED(TM)- 15 SX; HEMODIALYZER – Asahi KASEI; REXEED(TM)- 15 SX; HEMODIALYZERdialysis filter                Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products; though there is no sufficient information to date to conclusively link these adverse events to the products.

Cordis Corporation          Sep-21-2012       Sleek OTW***REF 426-1201X***Inflated Balloon – Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies; Ltd.***Moyne Upper; Enniscorthy Co Wexford; Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road; Cashel; Co. Tipperary; Ireland***Tel: +353–(0)62-70000.The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip.  The hub/"Y" connector consists of a through lumen; allowing the catheter to track over a guidewire; and a balloon port; used to inflate the balloon.  The catheter shaft is small beneath the balloon achieve low profile.  The distal tip is further tapered to accept the appropriate guidewire.  Platinum iridium bands serve to locate the balloon under fluoroscopy.  A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.  On 1/20/2011 Cordis Corporation ; Miami Lakes; FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688.  Product is incorrectly labeled.

Cordis Corporation          Sep-21-2012       Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon – Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies; Ltd.***Moyne Upper; Enniscorthy Co Wexford; Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road; Cashel; Co. Tipperary; Ireland***".The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip.  The hub/"Y" connector consists of a through lumen; allowing the catheter to track over a guidewire; and a balloon port; used to inflate the balloon.  The catheter shaft is small beneath the balloon achieve low profile.  The distal tip is further tapered to accept the appropriate guidewire.  Platinum iridium bands serve to locate the balloon under fluoroscopy.  A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter.         On 1//20/2011 Cordis Corporation ; Miami Lakes; FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688.  Product is incorrectly labeled.

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit.Product Code: DUET4548A.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit.Product Code:  DUET4535.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit.Product Code: DUET4535A.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit.Product Code: DUET4548.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit.Product Code: DUET6048A.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS  may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading UnitProduct Code: DUET6035.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.                Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit.Product Code: DUET6035A.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Covidien LP         Sep-21-2012       Covidien Duet TRS Loading Unit – Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit.Product Code: DUET6048.Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal; gynecologic and pediatric surgery for resection; transection and creation of anastomoses. They may be used for transection and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas.               Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

OPTI Medical Systems; Inc           Sep-21-2012       BP7561 OPTI CCA-TS B-Lac Cassette – BP7561 OPTI CCA-TS B-Lac Cassette (25 per box)Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH; PCOX2 PO2; lactate (lactic acid); total hemoglobin (tHb); and oxygen saturation (SO2); in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system; in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.             The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).

Terumo Cardiovascular Systems Corporation      Sep-24-2012       Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1 ASSEMBLY FLOW PODProduct Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.            Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo? Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS’ investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1; the sensor operates correctly if the tubing is installed and it is highly unli

RAYSEARCH LABORATORIES AB Sep-24-2012       SharePlan 1.1 – SharePlan 1.1; aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).  Manufacturing name RayAutoplan; aka t-RayAutoplan; commercial name (TomoTherapy) SharePlanIntended use: t-RayAutoplan is a software that; based on the planned dose distribution from a TomoPlan treatment planning system; generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans; the user selects and clinically approves a treatment plan and exports it electronically to DICOM; for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff; such as medical physicists; medical doctors or dosimetrists.           This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However; the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears; when importing RFA-files (.asc)

Applied Medical Resources Corp               Sep-25-2012       Irrigation Catheters – Irrigation Catheters (Models IRR-XXX-XX):Model Numbers & Description:IRR-023-10F;CATHETER IRRIGATION 10F 23CM;IRR-080-4F; CATHETER; IRRIGATION 4F 80CM;IRR-080-6F; CATHETER; IRRIGATION 6F 80CM.Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree. Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Applied Medical Resources Corp               Sep-25-2012       Biliary Catheters – Biliary Catheters (Models A47XX and CB0XXXXX):Model Numbers & Description:A4752; SYNTEL BILIARY 5F-23CM CATHETER;A4754; SYNTEL BILIARY 5F-40CM CATHETER;A4762; SYNTEL BILIARY 6F-23CM CATHETER;CB052308; SYNTEL BILIARY 5F-23CM CATH;CB054008; SYNTEL BILIARY 5F-40CM CATH;CB062313; SYNTEL BILIARY 6F-23CM CATH.Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.     Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Abbott Vascular                Sep-25-2012       Armada Catheters – Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.        Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.

Applied Medical Resources Corp               Sep-25-2012       Embolectomy Catheters – Embolectomy Catheters (Models A44XX; A4FXX; CE0XXXST; and CE0XXX):Model Numbers & Description:A4402; 3F-40CM; SYNTEL RT-EMB;A4403; 3F-80CM; SYNTEL RT-EMB;A4404; 4F-40CM; SYNTEL RT-EMB;A4405; 4F-80CM; SYNTEL RT-EMB;A4406; 5F-80CM; SYNTEL RT-EMB;A4407; 6F-80CM; SYNTEL RT-EMB;A4408; 7F-80CM; SYNTEL RT-EMB;A4F00; 2F-60CM (PREM) SYNTEL CATHETER;A4F01; 2F-80CM; (PREM) SYNTEL CATHETER;A4F02; 3F-40CM; (PREM) SYNTEL CATHETER;A4F03; 3F-80CM; (PREM) SYNTEL CATHETER;A4F04; 4F-40CM; (PREM) SYNTEL CATHETER;A4F05; 4F-80CM; (PREM) SYNTEL CATHETER;A4F06; 5F-80CM; (PREM) SYNTEL CATHETER;A4F07; 6F-80CM; (PREM) SYNTEL CATHETER;A4F08; 7F-80CM; (PREM) SYNTEL CATHETER;CE0260ST; L2F-60CM PREM SYNTEL CATH;CE0280ST; L2F-80CM PREM SYNTEL CATH;CE0340ST; 3F-40cm (PREM) SYNTEL CATHETER;CE0380ST; 3F-80CM PREM SYNTEL CATH;CE0440ST; 4F-40CM PREM SYNTEL CATH;CE0480ST; 4F-80CM PREM SYNTEL CATH;CE0580ST; 5F-80CM PREM SYNTEL CATH;CE0680ST; 6F-80cm (PREM) SYNTEL CATHETER;CE0780ST; 7F-80CM PREM SYNTEL CATH;CE0340; 3F-40cm; SYNTEL RT-EMB;CE0380; 3F-80cm; SYNTEL RT-EMB;CE0440; 4F-40cm; SYNTEL RT-EMB;CE0480; 4F-80cm; SYNTEL RT-EMB;CE0580; 5F-80cm; SYNTEL RT-EMB;CE0680; 6F-80cm; SYNTEL RT-EMB;CE0780; 7F-80cm SYNTEL RT-EMB.BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.                Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Neomend Inc    Sep-25-2012       Progel Pleural Air Leak Sealant – Progel Pleural Air Leak Sealant; Model #: PGPS002Lot #: 111202-002Product Usage:The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with; for example; sutures or staples; of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.       Product was distributed with an incorrect expiration date. Product was labeled with anexpiration date of 2013-04 and should have been labeled with 2012-09.

Hologic; Inc.        Sep-25-2012       Hologic Fluoroscan Mini C-Arm Model with InSight2 – Hologic Fluoroscan Mini C-Arm Model with InSight2; Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient; including but not limited to surgical orthopedic and podiatry use; critical and emergency procedures; and light anatomy imaging situation.     InSight2; version 4.0 and 4.0.1 – DICOM images stored in PACS may be flipped 180?around vertical axis.InSight FD; version 5.0.1 and 5.0.2 – DICOM images stored in PACS may be lipped 180? around vertical axis as well as 180? around a horizontal axis.

Hologic; Inc.        Sep-25-2012       Hologic Fluoroscan Mini C-Arm Model with InSight- FD – Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient; including but not limited to surgical orthopedic and podiatry use; critical and emergency procedures; and light anatomy imaging situation.   Fluoroscan Mini C-Arm models -InSight2; version 4.0 and 4.0.1 – DICOM images stored in PACS may be flipped 180?around vertical axis.InSight FD; version 5.0.1 and 5.0.2 – DICOM images stored in PACS may be lipped 180? around vertical axis as well as 180? around a horizontal axis.

Linvatec Corp. dba ConMed Linvatec      Sep-25-2012       Light Source; Endoscopic; Xenon Arc – ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source              Linvatec Corporation dba ConMed Linvatec; Largo; FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.

Linvatec Corp. dba ConMed Linvatec      Sep-25-2012       Light Source; Endoscopic; Xenon Arc – ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec  Xenon Universal Light Source         Linvatec Corporation dba ConMed Linvatec; Largo; FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.

Terumo Cardiovascular Systems Corporation      Sep-25-2012       Terumo Advanced Perfusion System 1 Flow Module – Terumo Advanced Perfusion System 1 Flow Moduleindicated for use in extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.       Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS’ investigation found that the malfunction was caused by an improper component on a circuit board used in a populat

Philips Medical Systems (Cleveland) Inc Sep-25-2012       Brilliance 6; Brilliance 16; MX8000 Dual v. Exp; GEMINI Dual – Computed Tomography X-Ray Systems; (Brilliance 6; Brilliance 16; MX8000 Dual v. Exp; GEMINI Dual); Philips Healthcare Systems; Cleveland; OH.The Brilliance 6; 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head; body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction. A bolt which attaches the oil accumulator within the gantry may fail; resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

Invacare Corporation     Sep-26-2012       I-Fit" Shower Chair – Invacare¿ I-Fit" Shower Chair (Models 9780; 9781; 9781-1); Invacare Corporation; Elyria; OH 44035.These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.     On August 6; 2012; Invacare voluntarily recalled the Invacare? I-Fit" Shower Chair (Models 9780; 9781; 9781-1) based on the return; quality and adverse event data received.

Imaging Sciences International; LLC         Sep-26-2012       DEXIS Imaging Suite – DEXIS Imaging Suite – catalog number 1.008.7932; version numbers 10.0.0 through 10.0.3Radiological Image Processing System               A condition can occur during renumbering of the patient database using the DEXCopy feature.  When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present; the software will assign all subsequent records to the first patient record; resulting in mixed patient records.  In order for this problem to occur several conditions need to be met: 1)

Greatbatch Medical        Sep-26-2012       Boston Scientific; Z Flex 270;  Steerable Sheath – Boston Scientific; Z Flex 270;  Steerable Sheath; Sterile EO; Rx only; Distributed by Boston Scientific Corporation; One Boston Scientific Place; Natick; MA 01760-1537; Manufactured by Greathbatch Medical; 2300 Berkshire Lane North; Minneapolis; MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.                During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters; the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.

Varian Medical Systems; Inc. Oncology Systems                Sep-26-2012       Varian brand Eclipse Treatment Planning System – Varian brand Eclipse Treatment Planning System; Model Number: H48; Eclipse 8.9 and 10.0Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc.; Palo Alto; CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon; electron and proton beams; as well as for internal irradiation (brachytherapy) treatments. In addition; the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.      Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.

Integra Limited Sep-26-2012       MAYFIELD¿ Horseshoe Gel Pads – Right Gel Pad – The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions.  Those devices provide cranial stability and immobility for various craniotomies and spinal procedures.The Gel Pads are supplied to users in labeled plastic bags; 1 per bag.Product Usage:The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.  An investigation of customer complaints identified that for two product lots; Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients; onl

Integra Limited Sep-26-2012       MAYFIELD¿ Horseshoe Gel Pads – Left Gel Pad – The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions.  Those devices provide cranial stability and immobility for various craniotomies and spinal procedures.The Gel Pads are supplied to users in labeled plastic bags; 1 per bag.Product Usage:The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.  An investigation of customer complaints identified that for two product lots; Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients; onl

Siemens Medical Solutions USA; Inc        Sep-26-2012       Siemens Magnetom Skyra; Verio; Spectra and Biograph MMR – Siemens Magnetom Skyra; Verio; Spectra and Biograph MMRNuclear Magnetic Resonance Imaging System and Tomographic Imager      When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and; in addition at an off-center position with respect to the head-foot direction; the coil can heat up in the area of the electronic housing (white plastic lids).

Alere San Diego; Inc.      Sep-26-2012       Alere Triage TOX Drug Screen 9 Panel – Alere Triage TOX Drug Screen 9 Panel; P/N: 94402.The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes; including assays for acetaminophen/paracetamol; amphetamines; methamphetamines; barbiturates; benzodiazepines; cocaine; opiates; phencyclidine; THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.            Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP; BAR; and PCP; the threshold ranges may not be consistently set correctly in all meters.

Philips Healthcare Inc.    Sep-27-2012       System; X-ray Stationary – Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector; Dual Detector; Release 3)System codes: 712020; 712022; 712025This system is used for making X-ray exposures for diagnostics.    The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may falldown

Linvatec Corp. dba ConMed Linvatec      Sep-27-2012       24K Arthroscopy Outflow/Suction Tubing Set*** – Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set***This Arthroscopy Tubing Set is intended for use; in conjunction with the ConMed Linvatec 24k Pump; for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.     ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.

KCI USA; Inc.      Sep-27-2012       BariAir Therapy System – BariAir Therapy SystemThe BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy; pulsation; percussion; Turn Assist. flexible patient positioning capabilities and built-in scales for patients weighing 300 Ib* to 850 Ib ([136*-386 kg] including accessories). The BariAir Therapy System is indicated to aid in: " Patients whose body weight and size pose a significant risk or care management issue to the patient or staff during the performance of routine nursing care. " Large patients weighing between 300 Ib* and 850 Ib (136*-386 kg) including accessories. " Large patients who are difficult to turn. " Preventing and treating pressure ulcers. " Large patients requiring percussion therapy.     KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent.  The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position.  KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position.  In a small number of instances; this allow

Mc-NEIL-PPC; Inc.            Sep-27-2012       KY LIQUIBEADS Vaginal Moisturizer – KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC; Inc. Skillman; NJ 08558-9418; UPC 380041087704; 380040087958.Personal lubricant   Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application.  This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS.  JJHP received a Warning Letter on May 23; 2012 indicating that thi

Micro Therapeutics Inc; Dba Ev3 Neurovascular Sep-27-2012       UltraFlow HPC Flow Directed Micro Catheter – UltraFlow HPC Flow Directed Micro Catheter; Model # 105-5065.Product Usage:The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.            The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

Micro Therapeutics Inc; Dba Ev3 Neurovascular Sep-27-2012       Marathon Flow Directed Micro Catheter – Marathon Flow Directed Micro Catheter; Model #105-5055.Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.           The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

Toshiba American Medical Systems Inc  Sep-27-2012       TSX-301A/2 Aquilion One CT System – TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry; patient couch (table) and peripheral cabinets used for data processing and display.This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system; when used by a trained professional; is capable of proving data for dynamic and perfusion studies of organs and extremities.     The SureStart function may not operate in the usual manner; and you may obtainabnormal analysis results when using the cerebral blood flow analysis function.

Alcon Research; LTD.      Sep-27-2012       Alcon 23G Non-Valved Trocar Cannula and Infusion Cannula – This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak; Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm); Constellation 23G Total PLUS Pak; Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit.  Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.           This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.

Zimmer; Inc.       Sep-28-2012       VerSys Femoral Head Provisional – 00789502601 VerSys Femoral Head Provisional 26mm -3.500789502602 VerSys Femoral Head Provisional 26mm +000789502603 VerSys Femoral Head Provisional 26mm +3.500789502604 VerSys Femoral Head Provisional 26mm +700789502605 VerSys Femoral Head Provisional 26mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometry y and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.      Complaints have been received reporting sub-optimal fit between provisional femoralheads (VerSys and MIS) and the mating components (i.e. stems and provisional femoralnecks); in some cases alleging the fit was too loose and in other cases; alleging the fit wastoo tight. Some reports of intraoperative dislodging of the provisional head have alsobeen received. Fourteen (14) of the complaints

Zimmer; Inc.       Sep-28-2012       Neck Taper – 12/14 Neck Taper00789504001 VerSys Femoral Head Provisional 40mm -3.500789504002 VerSys Femoral Head Provisional 40mm +000789504003 VerSys Femoral Head Provisional 40mm +3.500789504004 VerSys Femoral Head Provisional 40mm +700789504005 VerSys Femoral Head Provisional 40mm +10.5MIS FemoralThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.   Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Neck Taper – 12/14 Neck Taper00789503201 VerSys Femoral Head Provisional 32mm -3.500789503202 VerSys Femoral Head Provisional 32mm +000789503203 VerSys Femoral Head Provisional 32mm +3.500789503204 VerSys Femoral Head Provisional 32mm +700789503205 VerSys Femoral Head Provisional 32mm +10.5The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.            Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Neck Taper – 12/14 Neck Taper00789503601 VerSys Femoral Head Provisional 36mm -3.500789503602 VerSys Femoral Head Provisional 36mm +000789503603 VerSys Femoral Head Provisional 36mm +3.500789503604 VerSys Femoral Head Provisional 36mm +700789503605 VerSys Femoral Head Provisional 36mm +10.5The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.            Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Neck Taper – 12/14 Neck Taper00789502801 VerSys Femoral Head Provisional 28mm -3.500789502802 VerSys Femoral Head Provisional 28mm +000789502803 VerSys Femoral Head Provisional 28mm +3.500789502804 VerSys Femoral Head Provisional 28mm +700789502805 VerSys Femoral Head Provisional 28mm +10.512/14 Neck TaperThe provisional heads replicate final femoral implant geometery and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.      Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X2200780302202 MIS 12/14 Slotted Femoral Head Provisional +0X2200780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.      Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X2600780302602 MIS 12/14 Slotted Femoral Head Provisional +0X2600780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X2600780302604 MIS 12/14 Slotted Femoral Head Provisional +7X2600780302605 MIS 12/14 Slotted Femoral Head Provisional +10.5X26The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.                Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       VerSys Femoral Head Provisional – 00789502202 VerSys Femoral Head Provisional 22mm +000789502203 VerSys Femoral Head Provisional 22mm +3.500789502220 VerSys Femoral Head Provisional 22mm -200789502230 VerSys Femoral Head Provisional 22mm +312/14 Neck TaperThe provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.         Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (i.e. stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have alsobeen received. Fourteen (14) of the complaints al

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780303602 MIS 12/14 Slotted Femoral Head Provisional +0X3600780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780303604 MIS 12/14 Slotted Femoral Head Provisional +7X3600780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X3600780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780304002 MIS 12/14 Slotted Femoral Head Provisional +0X3600780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780304004 MIS 12/14 Slotted Femoral Head Provisional +7X3600780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.            Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780303602 MIS 12/14 Slotted Femoral Head Provisional +0X3600780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780303604 MIS 12/14 Slotted Femoral Head Provisional +7X3600780303605 MIS 12/14 Slotted Femoral Head Provisional +10.5X3600780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X3600780304002 MIS 12/14 Slotted Femoral Head Provisional +0X3600780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X3600780304004 MIS 12/14 Slotted Femoral Head Provisional +7X3600780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.            Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X3200780303202 MIS 12/14 Slotted Femoral Head Provisional +0X3200780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X3200780303204 MIS 12/14 Slotted Femoral Head Provisional +7X3200780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X3200780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.           Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Zimmer; Inc.       Sep-28-2012       Slotted Femoral Head Provisional – 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X2800780302802 MIS 12/14 Slotted Femoral Head Provisional +0X2800780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X2800780302804 MIS 12/14 Slotted Femoral Head Provisional +7X2800780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X2800780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28The provisional heads replicate final femoral implant geometry and are used to trial range of motion; joint stability; and determine appropriate femoral head size and offset during total hip arthroplasty.           Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks); in some cases alleging the fit was too loose and in other cases; alleging the fit was too tight.  Some reports of intraoperative dislodging of the provisional head have also been received.  13 of the complaints allege that th

Biomet; Inc.        Sep-28-2012       Optilock – Optilock 2.7 mm Screw Inserter.Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations; osteotomies and non-unions of the proximal humerus; particularly in osteopenic bone. The System is intended for fixation of fractures; osteotomies and non-unions of the olecranon; humerus; radius; ulna; particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones); including use in osteopenic bone.            Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw

Stryker Howmedica Osteonics Corp.       Sep-28-2012       Stryker Orthopaedics – Stryker Orthopaedics Restoration Modular Cone Body TrialsStryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork; Ireland.The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.         Stryker Orthopaedics has become aware of a burr; or a metal shaving; observed in the internal threaded portion of the Cone Body Trial. The typical size of the shaving observed was 1-2 mm in length and 0.037 mm squared in cross section.

Biomet; Inc.        Sep-28-2012       Optilock – Optilock T15 AO Driver (3.5mm).Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations; osteotomies and non-unions of the proximal humerus; particularly in osteopenic bone. The System is intended for fixation of fractures; osteotomies and non-unions of the olecranon; humerus; radius; ulna; particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones); including use in osteopenic bone.            Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw

Stanley Security Solutions; Inc.  Sep-28-2012       Tabs Professional Voice + Monitor; Model 25223 – Tabs Professional Voice + Monitor; with wire bracket; Model 25223.  Stanley Security Solutions; Inc.; Lincoln; NE.Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed; chair; room or wheelchair.   The monitor may fail to sound an alarm

Stanley Security Solutions; Inc.  Sep-28-2012       Tabs Professional Voice + Monitor; Model 25222 – Tabs Professional Voice + Monitor; includes one wall bracket; Model 25222.  Stanley Security Solutions; Inc.; Lincoln; NE.Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed; chair; room or wheelchair.      The monitor may fail to sound an alarm

Stanley Security Solutions; Inc.  Sep-28-2012       Tabs Professional Monitor; Model 25025 – Tabs Professional Monitor; without pull cord or wall bracket; Model 25025.  Stanley Security Solutions; Inc.; Lincoln; NE.Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed; chair; room or wheelchair.      The monitor may fail to sound an alarm

Stanley Security Solutions; Inc.  Sep-28-2012       Tabs Professional Monitor; Model 25022 – Tabs Professional Monitor; includes one wall bracket; Model 25022.  Stanley Security Solutions; Inc.; Lincoln; NE.Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed; chair; room or wheelchair.   The monitor may fail to sound an alarm

Stanley Security Solutions; Inc.  Sep-28-2012       Tabs Professional Monitor; Model 25023 – Tabs Professional Monitor; without wall bracket; Model 25023.  Stanley Security Solutions; Inc.; Lincoln; NE.Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed; chair; room or wheelchair.  The monitor may fail to sound an alarm

Philips Healthcare Inc.    Sep-28-2012       Philips Healthcare – Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543.Product Usage:Stationary radiographic System               Hook does not securely hold the footplate in vertical position; causing the footplate to disengage and may fall on patient or operator

Zimmer; Inc.       Sep-28-2012       Persona Personalized Knee System – Cemented Tibial DrillProduct Usage:The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.                Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due tothree reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone.The investigation into the reports that have been received found that the perforations are occurring while using theCemented Tibial Drill. The perforations have o

Eos Imaging Inc Sep-28-2012       EOS System – EOS X-ray Medical Diagnostic ; X-ray Equipment SystemDigital Radiography used in general radiographic examination.           It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.