Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
CareFusion 303; Inc. Jul-26-2012 Alaris PC unit – Alaris PC unit model 8015Product Usage: The device is labeled for prescription use only. The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen.
Respironics; Inc. Jul-23-2012 Respironics Trilogy 100; 200; and 202 Ventilators – Respironics Trilogy 100; 200; and 202 VentilatorsThe Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home; institution/hospital; and portable applications such as wheelchairs and gurneys; and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator. The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
B. Braun Medical; Inc. Jul-16-2012 Infusomat(R) Space Pump – Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed ‘G03’); 686E030003; 686F030005; 686F030007; 686G030002; and 686G030102.Intended for use with adults; pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications; blood and blood products indicated for infusion through FDA approved routes of administration. Firm became aware of the potential for breakage of the anti free flow clip catch; located on the inside of the pump door; when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened; free flow protection is still ensured. However; after the set is manually removed from the pump without the closure of t
CareFusion 203; Inc. Jul-16-2012 EnVe Ventilator – CareFusion EnVe VentilatorDesigned for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support; delivered invasively or non-invasively. It is not intended for homecare use. CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.
Alere San Diego; Inc. Jul-06-2012 Alere Triage BNP PN 98000XR – Alere Triage BNP PN 98000XRIntended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). Certain lots of the affected products may have significantly decreased precision relative to the package insert; which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Alere San Diego; Inc. Jul-06-2012 Alere Triage Profiler SOB Panel PN 97300 – Alere Triage Profiler SOB Panel PN 97300Used for the determination of creatine kinase MB; myoglobin; troponin I; B-type natriuretic peptide; and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. Certain lots of the affected products may have significantly decreased precision relative to the package insert; which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Alere San Diego; Inc. Jul-06-2012 Alere Triage Cardiac Panel PN 97000HS – Alere Triage Cardiac Panel PN 97000HSUsed for the quantitative determination of creatine kinase MD (CK–MB); myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. Certain lots of the affected products may have significantly decreased precision relative to the package insert; which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Alere San Diego; Inc. Jul-06-2012 Alere Triage CardioProfiler Panel PN 97100CP – Alere Triage CardioProfiler Panel PN 97100CPUsed for the quantitative determination of creatine kinase MB; myoglobin; troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. Certain lots of the affected products may have significantly decreased precision relative to the package insert; which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Alere San Diego; Inc. Jul-06-2012 Triage D-dimer PN 98100 – Triage D-dimer PN 98100Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. Certain lots of the affected products may have significantly decreased precision relative to the package insert; which could result in an increased frequency of false positive or false negative results. These false positive and false negative results are unpredictable within lots and may not be detected by Quality Control testing.
Maquet Cardiovascular Us Sales; Llc Jul-06-2012 FLOW-I Anesthesia System – FLOW-I Anesthesia SystemThe system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe; as well as in supporting patients with a limited ability to breathe. A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Maquet Medical Systems; Usa Jul-30-2012 Magnus Carbon-Fibre Table Top – Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before; during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment. As a result of a small number of customer complaints; MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23; 2010 and February 28; 2012 and distributed between November 11; 2010 and April 6; 2012. There is a potential issue with the motor brakes for the longitudinal shift drive; and the tilt drive.
Zimmer Inc. Jul-27-2012 NEXGEN¿ Complete Knee Solution Femoral and Accessory tool – Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor; REF 00-5901-026-00; Non-SterileZimmer; Warsaw IndianaThe instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use; posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces arecontributing to the instrument
Zimmer Inc. Jul-27-2012 NEXGEN¿ Complete Knee Solution – Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor; REF 00-5901-026-40; Non-Sterile Zimmer; Warsaw IndianaThe instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use; posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces arecontributing to the instrument
Intuitive Surgical; Inc. Jul-27-2012 "KIT;DISPOSABLE ACCESSORY – KIT;DISPOSABLE ACCESSORY;3ARM;IS2000;5 PACK; Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Intuitive Surgical; Inc. Jul-27-2012 "INSTRUMENT ARM DRAPE – INSTRUMENT ARM DRAPE IS2000; 20 PACK: Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Intuitive Surgical; Inc. Jul-27-2012 "ACCESSORY BASE STARTER KIT – ACCESSORY BASE STARTER KIT;IS3000; Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Intuitive Surgical; Inc. Jul-27-2012 "KIT;DISPOSABLE ACCESSORY – KIT;DISPOSABLE ACCESSORY;4ARM;IS2000;5 PACK; Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Intuitive Surgical; Inc. Jul-27-2012 "KIT;DISPOSABLE ACCESSORY – KIT;DISPOSABLE ACCESSORY;3ARM;IS3000;5 PACK; Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Intuitive Surgical; Inc. Jul-27-2012 "KIT;DISPOSABLE ACCESSORY – KIT;DISPOSABLE ACCESSORY;4ARM;IS3000;5 PACK; Product Usage:The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems." Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Advanced Sterilization Products Jul-27-2012 STERRAD Cyclesure Biological Indicator (BI); – STERRAD Cyclesure Biological Indicator (BI); P/N 14324 are sold in cases; packaged as part of STERRAD System Validation kits and STERRAD test packs.The STERRAD CYCLESURE 24 Biological Indicator (BI); P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product’s labeled shelf-life.
Getinge USA Inc Jul-26-2012 Getinge – Getinge brand — large capacity; floor loading jet spray; washers for mechanical washing; intermediate level; thermal disinfection and drying of moisture and temperature stable Hospital case carts; sterilization containers; material handling carts; stands and utensils. — Model numbers Getinge 9120; 9122; 9125; and 9128 Getinge Disinfection AB is voluntarily correcting Washer Disinfectors; Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
Tripath Imaging; Inc. Jul-26-2012 PrepStain System – PrepStain PM Kit; T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit; T-AG (Catalog 490954); PrepStain PM Kit XLP; T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP; T-US-II (490423); PrepStain Prep Only PM Kit; T-US (Catalog 490429); PrepStain PM Kit; T-US (Catalog 490626); PrepStain PM Kit Europe; T-US (Catalog 490428).The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer; pre-cancerous lesions; atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. Some Prep Stain Kit; 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Stryker Howmedica Osteonics Corp. Jul-26-2012 Rejuvenate Modular Stems – Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial EstateCarrigtwohill County Cork; IrelandRejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah; NJ 07430.Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy; developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm; 34 mm; 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127; 130 and 132. The versions are 0; 8; 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System. Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29; 2012; Stryker has decided to remove the affected product from the field since there may be an
Stryker Howmedica Osteonics Corp. Jul-26-2012 ABG II Modular Hip Stem – ABG II Modular Hip StemStryker Howmedica Osteonics Corp. Mahwah; NJ 07430Stryker Ireland Carrigtwohill Industrial Estate; Carrigtwohill County Cork; Ireland.The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium; a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range – The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length; version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125; 130 and 135 neck angles. Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29; 2012; Stryker has decided to remove the affected product from the field since there may be an
Hill-Rom; Inc. Jul-26-2012 Affinity Four Birthing Bed P3700 – Affinity Four Birthing Bed P3700 Product Usage:The Affinity; Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor; Delivery; Recovery ) or LDRP (Labor; Delivery; Recovery; Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds. During review of our last braking system via that field corrective action; the system still did not meet our expectations; which is to eliminate the hazards of patient falling. Bed movement immediately prior to; or during the birthing process may still create distractions and delays; resulting in patient or caregiver falls; or contribute to a deviation in aprocedure; (e.g. IV insertion; epidural
Tripath Imaging; Inc. Jul-26-2012 PrepStain System – PrepStain Kit: 1.2 DiTi Cone.The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer; pre-cancerous lesions; atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. Some Prep Stain Kit; 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Tripath Imaging; Inc. Jul-26-2012 PrepStain System – PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone.The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer; pre-cancerous lesions; atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. Some Prep Stain Kit; 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Tripath Imaging; Inc. Jul-26-2012 PrepStain System – PrepStain Slide Processor.The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer; pre-cancerous lesions; atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide. Some Prep Stain Kit; 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Philips And Neusoft Medical Systems Co.; Ltd. Jul-26-2012 NeuViz 16 Multi-Slice CT Scanner System – NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system; and has a Part number 989605858501.The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO.; LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO.; LTD***ADDRESS: NEUSOFT PARK; HUNNAN INDUSTRIAL AREA; SHENYANG***CHINA***". One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner; which caused the Oil-accumulator to detach.
Siemens Medical Solutions USA; Inc Jul-26-2012 Siemens syngo.plaza – Siemens syngo.plaza. Radiological image processing system Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen; that all images are not loaded to Viewer but no error message is displayed to user.
Stryker Howmedica Osteonics Corp. Jul-26-2012 Howmedica Osteonics Corp. – Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp.; 59 Route 17; Allendale; NJ 07401. During primary Scorpio TKA procedures; the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and Tibial Templates (3750-0003/-0005/-0007/-0009/-0013) to prepare the tibia for baseplate implantation. Per the surgical protocol for Duracon and Scorpio Total Knee Systems with Xcelerate Instrumentation (LSPK31 03/03); tibial templates are used to determine the appropriate coverage of the tibial plateau. Once a template size is selected; the device is secured to the plateau with fixation pins; and the tibial punch tower is assembled by placing the tower onto the two small locating pins on the tibial template. A keel punch is then selected; assembled into the channel of the tower; and impacted with a mallet. Depending on the intended implant size; several keel punches of increasing size may be utilized to incrementally enlarge the cavity. Each keel punch is advanced until it fully seats on the tibial template. Tibial preparation is considered complete when the final keel punch fully seats on the tibial template. Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the channel of the tower was later determined to be undersized.
Mallinckrodt Inc Jul-26-2012 P/N 302050 HANDI FIL DISPOSABLE SYRINGE FILL TUBE – The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube; approximately 10 inches in length; with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.
Hospira Inc. Jul-25-2012 Hospira LifeShield Latex-Free 100 mL Burette Set – Hospira LifeShield Latex-Free 100 mL Burette Set; Convertible Pin; 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica; Hospira; Inc.; Lake Forest; IL 60045 USA; list 12722-65. Intended use: for the administration of fluids. The float valve in the burette sticks to the burette wall and does not open or close properly.
The Anspach Effort; Inc. Jul-25-2012 Anspach Single Use; Sterile Bone Cutting Burrs (Model SHD-4820DS) – .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1; 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX OnlyProduct Usage:Cutting and shaping bone including bones of the spine and cranium. Anspach Effort; Inc. Palm Beach Gardens; FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax; microMax; microMax Plus; eMax; eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
Bridgepoint Medical Jul-24-2012 Stingray Catheter – BridgePoint Medical; Stingray Catheter; REF M – 1000; Sterilized with Ethylene Oxide Gas; Prescription Only; Manufacturer BridgePoint Medical Inc. 13355 10th Ave N; Suite 110; Plymouth; MN 55441.Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System; the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. . BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter; Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical; Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem.
AGFA Corp. Jul-24-2012 IMPAX CV Reporting Non-Invasive Vascular (NIV)/Results Management (RM) NIV – IMPAX CV ReportingThe Results Management (RM)/IMPAX CV reporting component facilitates the quick; effective creating of digital structured reports for : adult catheterization and echocardiography; pediatric echocardiography; congenital heat disease; nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view; edit and sign the structured reports. When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module; "Right stenosis" appeared in the sentence display within the printed representation of the report.
Siemens Medical Solutions USA; Inc Jul-24-2012 ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist – ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X; Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Siemens became aware of a potential safety issue when using the "IMMEDIATE RESUMPTION" feature of the syngo RT Therapist 4.2 software after a Control Console interlock during the delivery of flattening-filter-free (Multiple-X) beams or segments; in a very rare scenario; the RT Therapist will send again the previously completed beam or segment for delivery to the control console; thus repeating th
Exactech; Inc. Jul-24-2012 OPTETRAK RBK***TIBIAL TRAY – Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED; CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville; FL 32653-1630***.The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion; dysfunction or prior patellectomy. Additionally; the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary; if the knee can be satisfactorily balanced and stabilized at the time of surgery. Exactech; Inc. Gainesville; FL is recalling their Optetrak Cemented Trapezoid Tibial Tray; Size 1F/1T; 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray; Finned; Cemented Tibial Tray; Size 2F/1T. Both trays have the potential to be mislabeled.
Exactech; Inc. Jul-24-2012 OPTETRAK***TIBIAL TRAY – Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T; 2F/1T***FOR CEMENTED USE ONLY***Exactech; Gainesville; FL 32653-1630.***REF 204-04-21***".The Optetrak Comprehensive Knee Systems are 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. In the USA; the Optetrak Comprehensive Knee System is indicated for cemented use only. Exactech; Inc. Gainesville; FL is recalling their Optetrak Cemented Trapezoid Tibial Tray; Size 1F/1T; 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray; Finned; Cemented Tibial Tray; Size 2F/1T. Both trays have the potential to be mislabeled.
Ortho-Clinical Diagnostics Jul-23-2012 VITROS 5;1 FS System Software – VITROS 5;1 FS System Software For use in the in-vitro quantitative; semi quantitative; and qualitative measurement of variety of analytes of clinical interest. software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Ortho-Clinical Diagnostics Jul-23-2012 VITROS 4600 Chemistry System Software – VITROS 4600 Chemistry System Software For use in the in-vitro quantitative; semi quantitative; and qualitative measurement of variety of analytes of clinical interest. software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Synthes USA HQ; Inc. Jul-23-2012 4.5mm TI Multiloc Screw Length 28MM – 4.5mm TI Multiloc Screw Length 28MM-SterileExpiration: 04/29/2012REF 04.019.028SManufactured or Distributed by Synthes (USA) 1101 Synthes Avenue; Monument CO 801324.5MM TI Multiloc Screw Length 28MM-SterileRef 04.019;038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head; below the articular surface). Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Synthes USA HQ; Inc. Jul-23-2012 4.5mm TI Multiloc Screw Length 38MM – 4.5mm TI Multiloc Screw Length 38MM-SterileExpiration: 04/29/2012REF 04.019.038SManufactured or Distributed by Synthes (USA) 1101 Synthes Avenue; Monument CO 801324.5MM TI Multiloc Screw Length 38MM-SterileRef 04.019;038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head; below the articular surface). Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Ortho-Clinical Diagnostics Jul-23-2012 VITROS 5600 Integrated System Software – VITROS 5600 Integrated System Software For use in the in-vitro quantitative; semi quantitative; and qualitative measurement of variety of analytes of clinical interest. software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
Leica Microsystems; Inc. Jul-20-2012 Leica M525 F50 surgical microscope – Leica M525 F50 Surgical Microscope; Article No. 10338422; Product Usage:The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.
Westone Laboratories; Inc. Jul-20-2012 OTO EASE – Oto Ease by Westone; labeled as a bacteria free; greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles.Product Usage:The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids. Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
Synthes USA HQ; Inc. Jul-20-2012 Universal Spinal System Lamina Hooks – Universal Spinal System Lamina HooksSynthes Medium TI Lamina Hook – Right 498.320Non sterileLOT 6876785Noncervical spinal fixation devices intended for posterior pedicle screw fixation; posterior hook fixation; or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS; which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease; spondylolisthesis; trauma; deformities or curvatures; tumor; stenosis and failed previous fusion. USS Lamina Hooks; Medium; Right are being recalled because the hooks are etched with the wrong part number – 498.321 (Lamina Hook; Medium; Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook; Medium; right).
OrthoPediatrics Corp Jul-20-2012 OrthoPediatrics Pediloc Locking Plate System – OrthoPediatrics PediLoc Locking Plate System; 4.5mm Contour Locking Compression Femur 8 Hole Plate Right.Used for pediatric patients as indicated for pelvic; small and long bone fractures. The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Terumo Cardiovascular Systems Corporation Jul-20-2012 The Terumo¿ Advanced Perfusion System – System 1 Base 220/240VThe Terumo¿ Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user.The potential hazards are dependent on the application
Terumo Cardiovascular Systems Corporation Jul-20-2012 The Terumo¿ Advanced Perfusion System – System 1 Base 100/120VThe Terumo¿ Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user.The potential hazards are dependent on the application
GE Healthcare; LLC Jul-19-2012 GE Healthcare Optima Mobile X-ray System – GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product; Optima XR200amx; ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
Stryker Spine Jul-19-2012 Stryker AVS Navigator – Stryker AVS Navigator Trials 6mm-15mmManufactured by:Stryker Spine SASZ.1 Marticot-33610-Cestas -France+33 (0) 5.57.97.06.30http;//www.stryker.comDistributed in the USA by Stryker Spine2 Pearl Court. AllendaleNJ 07401-1677 USA+1-201-780-8000Cestas France 33610.Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively. Beginning in February 2011; Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
Hitachi Medical Systems America Inc Jul-19-2012 Hitachi Scenaria CT System Software – Hitachi Scenaria CT System SoftwareProduct Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial; helical; gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA); Multi-planar reconstruction (MPR) and volume rendering. Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing; if a queue is suspended and the task order changed; the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data.
Philips Medical Systems (Cleveland) Inc Jul-19-2012 Brilliance CT 6-slice;16-slice; 40-channel; 64-channel;Big Bore Oncology & Brilliance iCT and iCT SP – Philips Brilliance 6; 16; 40; 64; Big Bore; iCT and iCT SP are Computed Tomography X-Ray Systems.The devices are Computed Tomography 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 Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.
Varian Medical Systems; Inc. Oncology Systems Jul-19-2012 Eclipse Treatment Planning System – Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; 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 algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization; the Monitor Units and dose distribution may not reflect
Alere San Diego; Inc. Jul-19-2012 Alere Triage Tox+MTD Drug Screen – Alere Triage Tox+MTD Drug Screen; PN 94400Product Usage:The Alere Triage TOX Drug Screen is a fluorescence immunoassay 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; methadone; 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. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result; particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result; a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS); Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results. A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
Teleflex Medical Jul-19-2012 Hudson RCI Concha Therm Neptune Humidifier – Hudson RCI Concha Therm Neptune Humidifier; Rx Only; Product Usage: Usage:Device that is intended to add moisture to; and sometime to warm; the breathing gases for administration to a patient. Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm; the alarm will not sound and could cause a potential delay in patient treatment.
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 5 pump 100V.he 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 9000 – Sarns Modular Perfusion System 9000; 115V with color screen.The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 9000 – Sarns Modular Perfusion System 9000; 220/240V with color screen.The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 9000 – Sarns Modular Perfusion System 9000; 100V with color screen.The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures; when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 4 pump 100V.The 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 5 pump 220/240V.The 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 4 pump 220/240V.The 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 5 pump 115V.The Sarns Modular Perfusion Systern 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 base; 4 pump 115V.The 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. Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst
Terumo Cardiovascular Systems Corporation Jul-19-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1. System 1 base 220/240V.The Terumo Advanced Perfusion System I 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 has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste
Epocal Inc Jul-19-2012 epoc Blood Analysis BGEM Test Cards – epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis SystemProduct Usage: Usage:epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
Terumo Cardiovascular Systems Corporation Jul-19-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1. System 1 base 100/120V.The Terumo Advanced Perfusion System I 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 has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity; false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syste
Gulf Fiberoptics; Inc. Jul-18-2012 GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. – GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm’s 510k due to light transmitting fiber material difference.
Integra Limited Jul-18-2012 Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments – Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments.Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping; dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification.
Becton Dickinson & Co. Jul-18-2012 BD Gram Stain Kit – BD Gram Stain Kit; containing 1- 250 mL bottle of Gram Crystal Violet; and additional reagents: Gram Iodine (Stabilized); Gram Decolorizer; Gram Safranin.Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Potential for increase level of artifacts to appear as large; spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
Becton Dickinson & Co. Jul-18-2012 Gram Crystal Violet 250 mL – Gram Crystal Violet 250 mL; catalog #212525; in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Potential for increase level of artifacts to appear as large; spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
Terumo Cardiovascular Systems Corporation Jul-17-2012 Terumo Advanced Perfusion System 1 – System 1 Base; 100/120V.The Terumo Advanced Perfusion System 1 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. Terumo? Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system’s base. Terumo Cardiovascular Systems’ initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause.Potential risks with the loss or
Terumo Cardiovascular Systems Corporation Jul-17-2012 Terumo Advanced Perfusion System 1 – System 1 Base; 220/240V.The Terumo Advanced Perfusion System 1 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. Terumo? Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system’s base. Terumo Cardiovascular Systems’ initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause.Potential risks with the loss or
EKOS Corporation Jul-17-2012 EkoSonic MACH4 Endovascular Device – EkoSonic MACH4 Endovascular Device (Catalog #500-55106; 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter; continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids; including thrombolytics; into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***".The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***".EkoSonic Endovascular System is a catheter; continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids; including thrombolytics; into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries. EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.
LMA North America Inc Jul-17-2012 LMA Esophageal Intubation Detector (EID); Catalog Number EID100 – LMA Esophageal Intubation Detector (EID); Catalog Number EID100The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation.
Kimberly-Clark Corporation Jul-16-2012 MicroCool Breathable Impervious Gown with Secure Fit Surgical; – MicroCool Breathable Impervious Gown with Secure Fit Surgical; (Large and X-Large); Made in Honduras.The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms; body fluids and particulate matter. Complaints were received of gowns pilling or balling; linting and abrades; blood strikethrough and fibers falling off the gowns.
Kimberly-Clark Corporation Jul-16-2012 MicroCool Breathable Impervious Surgical Gown – MicroCool Breathable Impervious Surgical Gown; (Large and X-Large); Sterile; Made in Honduras.The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms; body fluids and particulate matter. Complaints were received of gowns pilling or balling; linting and abrades; blood strikethrough and fibers falling off the gowns.
Stryker Howmedica Osteonics Corp. Jul-16-2012 Stryker Osteosynthesis – Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH; Professor-Kuntscher-Str. 1-5; 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics; 325 Corporate Drive; Mahwah; NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation; non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures. Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails.
Spacelabs Healthcare; Llc Jul-16-2012 Spacelabs Medical Xprezzon Bedside Monitor; Model 91393 – Spacelabs Medical Xprezzon Bedside Monitor; Model 91393; installations with Option C. It is a patient monitor with arrhythmia detection or alarms.The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal; the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays; network devices; serial devices; user input devices; audio systems; and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a hospital environment. There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor; model 91393; and the patient parameters will drop from the display. The parameters return after power cycling the monitor.
GE Healthcare; LLC Jul-16-2012 GE Healthcare; Invasive Blood Pressure Care Cables. – GE Healthcare; Invasive Blood Pressure Care Cables.Product ID Number: 2016995-001; 2016995-002; 2016995-003; 2016995-004. GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring; the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly.
Abbott Molecular Jul-14-2012 Abbott Molecular Bar Code Scanner User’s Guide – Abbott Molecular Bar Code Scanner User’s Guide; instructions for setting up the Bar Code Scanner LN 6L89-01; a component of the Abbott m2000 Instrument System; Abbott Molecular Inc.; Des Plaines; IL 60018 USA; list number 06L88-02.Language configuration bar codes – Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak); the scanner is in English format. If a keyboard other than the English keyboard is being used; the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User’s Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language. In the Abbott Molecular Bar Code Scanner User’s Guide; List Number 6L88-02/09; the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format.The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Ab
Etac Supply Center Ab Jul-14-2012 Etac Ono; Avant; and Salsa Walkers – Etac¿ Ono Walker; Etac¿ Avant Walker; and Etac¿ Salsa Walker.These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG. The recall has been initiated because there is the potential that users may fall and become injured; with the potential for serious injury; including bone fracture. One death occurred in a user fall incident; but it is unclear whether the fall was caused by the loss of a wheel. Among the walkers distributed worldwide; Etac? has received a total of 49 reports from Europe and Japan of wheels falling
Terumo Cardiovascular Systems Corporation Jul-13-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1System 1 Base; 100/120V.The Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are:" The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single ‘?’ symbol on a pump or module icon on the CCM" The fai
Terumo Cardiovascular Systems Corporation Jul-13-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1System 1 Base; 220/240V.The Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are:" The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single ‘?’ symbol on a pump or module icon on the CCM" The fai
Stingray Surgical Products; LLC Jul-13-2012 Bipolar Forceps – Bipolar Forceps model number: S02-XXX; S03-XXX; P02-XXX; and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp; manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator. On 05/23/2012; Stingray Surgical Products; LLC.; Boca Raton; FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.
DeRoyal Industries Inc Jul-13-2012 DeRoyal Surgical Kits and Trays – Custom surgical kits and trays:GEO-MED TOTAL KNEE PACK PGYBK; REF 89-6664.04GEO-MED TOTAL HIP PACK; REF 89-6664.03surgical kits Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape; that is intended to aid in the prevention of patient’s fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga; was not applied during the manufacturing process.
Elekta; Inc. Jul-12-2012 Focal SIM – Focal SIMPlanning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
superDimension; Inc Jul-12-2012 superDimension Systems – superDimension Systems AAS00016-xx with Software Version 4.0-4.9.Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use. superDimension; Inc.; is conducting a recall of certain superDimension Systems operating Software Version 4.0 – 4.9. The affected systems are sold under the product code AAS00016-xx.The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically; the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide
PSC Industries Inc Jul-12-2012 Bipolar Sterile Single Use 7-1/8 Electrosurgical Bayonet Forceps – Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips; Sterile Single Use Surgical/Bipolar Forceps; Model #20-1360I; 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch; 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords – Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. Firm officials reported to CIN-DO that the outer carton label of this sterile; single use device is misbranded in that it lists an incorrect expiration date. The outer carton label lists the sterile expiration date as: 2012-02-(28) [the manufacture date] ; however the device pouch label lists the sterile date as: 2017-02-(28). The pouch label lists the correct sterile expiration date.
Philips Medical Systems (Cleveland) Inc Jul-12-2012 Intellispace Portal – Intellispace Portal softwareProduct Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network. In the Multi-Modality Tumor Tracking application; when changing the contours of the lesion using the editing mode "edit contour" tool; the measurements are not recalculated causing discrepancies with the lesion measurements.
Elekta; Inc. Jul-12-2012 Monaco – MonacoProduct Usage:Planning of radiation therapy Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
PSC Industries Inc Jul-12-2012 Bipolar Sterile Single Use 7-1/8 Electrosurgical Bayonet Forceps – Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips; Sterile Single Use Surgical/Bipolar Forceps; Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch; 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords – Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures. Firm officials reported to CIN-DO that for this device; in the labeling on the inner Tyvek peel pouch; the letter ‘E’ in Electrosurgical was turned into an ‘X’ and the number ‘5" of the (mm tips) was turned into a ‘0’. This affected the description and some of the text of the labels. However; it did not t affect the Part Number and Lot Number on the label.
PSC Industries Inc Jul-12-2012 Sterile Single Use 8.25" Electrosurgical Irrigating Bayonet Forceps – Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips; Electrosurgical Irrigating Bipolar Forceps; Model #20-0431; 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue. Firm officials reported to CIN-DO that for this device; in the labeling on the inner Tyvek peel pouch; the letter ‘E’ in Electrosurgical was turned into an ‘X’ and the number ‘5" of the (mm tips) was turned into a ‘0’. This affected the description and some of the text of the labels. However; it did not t affect the Part Number and Lot Number on the label.
PSC Industries Inc Jul-12-2012 Monopolar Reusable Bayonet Forceps – Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable; Model #41604; 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes.Monopolar Reusable Forceps – are intended for use in cutting and coagulating tissue during surgical procedures. Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).
PSC Industries Inc Jul-12-2012 Bipolar electro-surgical bayonet forceps 7.75" (196.0mm) 0.5 mm tips – Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable; Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes.Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures. Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
PSC Industries Inc Jul-12-2012 Bayonet Forceps 8.25" (209.6mm) 0.5 mm tips Electro-surgical Bipolar Forceps – Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips; Sterile Single Use Surgical/Bipolar Forceps; Model #20-13420; 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords – Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures Firm officials reported to CIN-DO that for this device; in the labeling on the inner Tyvek peel pouch; the letter ‘E’ in Electrosurgical was turned into an ‘X’ and the number ‘5" of the (mm tips) was turned into a ‘0’. This affected the description and some of the text of the labels. However; it did not t affect the Part Number and Lot Number on the label.
Philips Healthcare Inc. Jul-11-2012 Philips Healthcare – Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03The 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 Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG
Philips Medical Systems (Cleveland) Inc Jul-11-2012 Intellispace Portal and Extended Brillance Workspace – IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
PSC Industries Inc Jul-11-2012 Electrode Electrosurgical/Extendable Pencil – Button Switchpens; w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils; 510(k) #K936304; Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles — Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures. The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time; they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
PSC Industries Inc Jul-11-2012 Electrode Electrosurgical/Extendable Pencil – Button Switchpens; w/Extendable Needle Electrode 10 mm Exposure; Single Use device; Electrosurgical./Extendable Pencils; 510(k)#K936304; Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box.Pens/Pencils and Handles — Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures. The Tyvek pouch label for this device states: ‘with holster’; however; this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time; they reported various labeling errors with their Button Switch Pen Electrode Electrosurgical /Extendable Pencils.
Philips Medical Systems (Cleveland) Inc Jul-11-2012 Intellispace Portal – Intellispace Portal software.Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application; but does not display a warning message informing the user that diff
GE OEC Medical Systems; Inc Jul-11-2012 GEHC OEC Axcess Cranial Pin – The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping; self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit.The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required. GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insertion. There is a possibility that breaking of the screws could lead to a health hazard.
Integra LifeSciences Corp Jul-10-2012 Pudenz Flushing Valve – Pudenz Flushing Valve with Integral Connectors; catalog number NL850-1330. Integra Neurosciences; Plainsboro; NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain. The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".
Stryker Howmedica Osteonics Corp. Jul-10-2012 Stryker Orthopaedics – Stryker Orthopaedics; Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah; NJ 07430. A subsidiary of Stryker Corp. Stryker France; ZAC Satorlas Green Pusignan; Av De Satolas Green 69881 Meyzeiu; Cedex France. Made in Ireland.The Definition PM femoral hip stem is a forged; collared; straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns; centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process. Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
Zimmer; Inc. Jul-10-2012 Pathfinder NXT – Pathfinder NXT Fixed Percutaneous Rod Holder; Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber; Rx only; non sterile.Product Usage:PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine. Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder; because complaints have been received that the rod holder tip maycrack or break when the rod is manipulated during surgery.
Zimmer; Inc. Jul-10-2012 Pathfinder NXT – Pathfinder NXT Fixed Percutaneous Rod Holder; Part numbers 3573-1 (angle handle) ; Stainless Steel / Silicone Rubber; Rx only; non sterile.Product Usage:The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique); Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder; because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
Advanced Neuromodulation Systems Inc. Jul-10-2012 Eon Mini Neurostimulation (IPG) System – Eon Mini Neurostimulation (IPG) System (Model 3788);The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome; intractable low back and leg pain. The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board; causing a short; and therefore; prematurely depletin
Terumo Cardiovascular Systems Corporation Jul-09-2012 The Terumo Advanced Perfusion System 1 – System 1 Base; 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in 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. Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use; such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
Cardiovascular Systems; Inc. Jul-09-2012 Stealth 360-degree Obital Atherectomy Device – CSI Stealth 360-degree Orbital Atherectomy Device (OAD); Part Number 70056-11; Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system.The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Terumo Cardiovascular Systems Corporation Jul-09-2012 The Terumo Advanced Perfusion System 1 – System 1 Base; 220/240V The Terumo Advanced Perfusion System 1 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 System 1 base includes an integrated backup battery in the event of power loss. Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use; such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – System 1 Base 220/240VThe Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions includestiff/difficult to adjust occlusion; loss of occlusion setting; unequal roller-to-roller occlusion and inability to adjust the occlusion.If it is
Stryker Endoscopy Jul-09-2012 Stryker – Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy; San Jose; CAThe Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The gravity steam; Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm’s evaluation that identified original validation was not done at worst case conditions.
GE Healthcare; LLC Jul-09-2012 Image Processing System – GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0; 4.1;or 4.2)The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from Positron Emission Tomography (PET). GE Healthcare has become aware of a potential safety issue due to incorrect alignment of fused CT and PET images associated with the CT/PET fusion capabilities of your Volume Viewer and CT/PET Fusion application. Volume Viewer allows two studies (one PET and one CT) that are registered in the same spatial domain to be viewed simultaneously in fused mode. The two images should be aligned to th
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – System 1 Base 100/120VThe Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions includestiff/difficult to adjust occlusion; loss of occlusion setting; unequal roller-to-roller occlusion and inability to adjust the occlusion.If it is
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – System 1 Base 220/240V.The Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions:" Unplanned pump stop or pause" Changes in pump speedIf it is necessary to replace a roller pump during cardiopu
Vital Signs Devices; a GE Healthcare Company Jul-09-2012 enFlow IV Fluid Warmer – enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER; MODEL100; EFLOW DISPOSABLE CARTRIDGE; MODEL 200 AND EFLOW AC POWER SUPPLY;MODEL 120).The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood; blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital; clinical and field environments to help prevent hypothermia. The EnFlow Warmer Strapdoes not meet the requirements of the biocompatibility standard (ISO 10993) for products that mayhave contact with skin for less than 24 hours.
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – System 1 Base 100/120VThe Terumo Advanced Perfusion System 1 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. Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions:" Unplanned pump stop or pause" Changes in pump speedIf it is necessary to replace a roller pump during cardiopu
Edwards Lifesciences; LLC Jul-09-2012 Rigid Suction Wand – Edwards Lifesciences Rigid Suction Wand; sterile. Model numbers S033 and SPC2081.Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1Electronic O2 Blender/Analyzer.The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1System 1 Base; 100/120V.The Terumo Advanced Perfusion System 1 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 electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
Terumo Cardiovascular Systems Corporation Jul-09-2012 Terumo Advanced Perfusion System 1 – Terumo Advanced Perfusion System 1System 1 Base; 220/240 V.The Terumo Advanced Perfusion System 1 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 electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas. Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
Smiths Medical ASD; Inc. Jul-09-2012 Smiths Medical HOTLINE 3 Blood and Fluid Warmer – Smiths Medical HOTLINE 3 Blood and Fluid Warmer;Reorder Numbers: HL-390Product Usage:The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product; for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures. These products are intended for use by appropriately trained healthcare professionals in clinical environments HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed ; the microswitch may become damaged and unusable
Abbott Point Of Care Inc. Jul-09-2012 iStat1 Analyzer – iStat1 AnalyzerAbbott Point of Care; Princeton; NJ 08540Model 200. The 37 degree tests for sodium; potassium; ionized calcium; hematocrit; pH; PCO2; PO2; and the i-Stat 200 analyzer as port of the i-Stat System; are intended for use in the in vitro quantitization of arterial; venous; or capillary whole blood Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Abbott Point Of Care Inc. Jul-09-2012 i-STAT1 Abaxis Analyzer – i-STAT1 Abaxis Analyzer; Abbott Point of Care; Princeton; NJ 08540 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Abbott Point Of Care Inc. Jul-09-2012 Military Kit Portable Clinical Analyzer – Military Kit Portable Clinical Analyzer ; Abbott Point of Care; Princeton; NJ 08540Model 200. The 37 degree tests for sodium; potassium; ionized calcium; hematocrit; pH; PCO2; PO2; and the i-Stat 200 analyzer as port of the i-Stat System; are intended for use in the in vitro quantitization of arterial; venous; or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Abbott Point Of Care Inc. Jul-09-2012 Fuso Analyzer 300F – Fuso Analyzer 300F; Abbott Point of Care; Princeton; NJ 08540Model 200. The 37 degree tests for sodium; potassium; ionized calcium; hematocrit; pH; PCO2; PO2; and the i-Stat 200 analyzer as port of the i-Stat System; are intended for use in the in vitro quantitization of arterial; venous; or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Abbott Point Of Care Inc. Jul-09-2012 i-STAT1 Abaxis Analyzer – i-STAT1 Abaxis Analyzer; Abbott Point of Care; Princeton; NJ 08540Model 200. The 37 degree tests for sodium; potassium; ionized calcium; hematocrit; pH; PCO2; PO2; and the i-Stat 200 analyzer as port of the i-Stat System; are intended for use in the in vitro quantitization of arterial; venous; or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Abbott Point Of Care Inc. Jul-09-2012 i-Stat Portable Clinical Analyzer; – i-Stat Portable Clinical Analyzer; Abbott Point of Care; Princeton; NJ 08540Model 200. The 37 degree tests for sodium; potassium; ionized calcium; hematocrit; pH; PCO2; PO2; and the i-Stat 200 analyzer as port of the i-Stat System; are intended for use in the in vitro quantitization of arterial; venous; or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Arjo; Inc. dba ArjoHuntleigh Jul-06-2012 Encore Mobile Patient Lifter – Encore Mobile Patient Lifter; manufactured by Arjo Ltd.; St. Catherine Street; Gloucester; GL1 2SL; England; U.K.; Models KKB5022-21US and KKB5042-21US.The Encore is designed to be used as a standing and raising aid; it is useful for short transfers from one sitting position to another; and to elevate a patient for toileting; repositioning; changing of incontinence pads or wound dressings; standing practice etc. it is not intended for long periods of suspension or transportation. ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Arjo; Inc. dba ArjoHuntleigh Jul-06-2012 Chorus Mobile Patient Lifter – Chorus Mobile Patient Lifter; manufactured by Arjo Ltd.; St. Catherine Street; Gloucester; GL1 2SL; England; U.K.; Models KKB5060-21US; KKB5062-21US and KKB5080-21US.The Chorus is designed to be used as a standing and raising aid; it is useful for short transfers from one sitting position to another; and to elevate a patient for toileting; repositioning; changing of incontinence pads or wound dressings; standing practice etc. it is not intended for long periods of suspension or transportation. ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Arjo; Inc. dba ArjoHuntleigh Jul-06-2012 Sara Plus Mobile Patient Lifter – Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V.; Heikant 5; B-3930 Hamont-Achel; Belgium; Models HEP0001-US and HEP1001-US.The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair; or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed. ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Impac Medical Systems Inc Jul-06-2012 MOSAIQ Oncology Information Systems – MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines.An image enabled electronic medical record system used for oncology workflow management.Manufactured by:Impac Medical Systems100 Mathilda Place; 5th floorSunnyvale; Ca 94086 Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults; the remaining Wedge MU was being erroneously set to zero.
Encision; Inc. Jul-06-2012 AEM Disposable Electrodes – AEM Disposable Electrodes; Device; Electrosurgical; Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation; removal; resection and coagulation of soft tissue in open; endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series.AEM Disposable Electrodes used as electrosurgical accessories intended for ablation; removal; resection and coagulation of soft tissue in open; endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.
Atom Medical Corporation Jul-06-2012 Dual Incu i – Dual Incu i; (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo; Bunkyo-Ku; Tokyo; Japan 113-0033 Usage: An incubator for infants. There is a potential for the device’s canopy to move unintentionally when using the incubator mode or radiant warmer mode.
Argon Medical Devices; Inc Jul-06-2012 Safedraw Venous Close Loop System – Safedraw Venous Close Loop System; Blood Sampling Set; packaged in a tyvek bag; Model/Part Number 688695; Argon Critical Care Systems; Singapore Pte. Ltd.; 198 Yishun Avenue 7; Singapore 768028.The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment. Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
Civco Medical Instruments Inc Jul-06-2012 CIVCO VirtuTRAX Instrument Navigator – CIVCO VirtuTRAX Instrument Navigator; Reusable non-sterile general purpose driveBAY; trakSTAR; electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5); Ref. 610-1080. The firm name on the label is CIVCO; Kalona; IA. The kit contains sensor component part number 410-240.The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Civco Medical Instruments Inc Jul-06-2012 CIVCO General Purpose Sensor – CIVCO General Purpose Sensor; Non-sterile reusable general purpose electromagnetic sensor; for use with 3D Guidance medSAFE trackers; Ref. 610-1067. The firm name on the label is CIVCO; Kalona; IA. The kit contains sensor component part number 410-240.The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Civco Medical Instruments Inc Jul-06-2012 CIVCO General Purpose Sensor – CIVCO General Purpose Sensor; Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY; driveBAY 2; trakSTAR; or trakSTAR2 trackers; Ref. 610-1066. The firm name on the label is CIVCO; Kalona; IA. The kit contains sensor component part number 410-240.The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Civco Medical Instruments Inc Jul-06-2012 CIVCO General Purpose Sensor – CIVCO General Purpose Sensor; Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY; driveBAY 2; trakSTAR; or trakSTAR2 trackers; Ref. 10441627. The firm name on the label is CIVCO; Kalona; IA. The kit contains sensor component part number 410-240.The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Civco Medical Instruments Inc Jul-06-2012 CIVCO VirtuTRAX Instrument Navigator – CIVCO VirtuTRAX Instrument Navigator; Reusable non-sterile general purpose driveBAY; trakSTAR; electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5); Ref. 5350925. The firm name on the label is CIVCO; Kalona; IA. The kit contains sensor component part number 410-240.The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Draeger Medical Systems; Inc. Jul-06-2012 Drager PT 4000 Phototherapy System – Drager PT 4000 Phototherapy System A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Terumo Cardiovascular Systems Corporation Jul-06-2012 Terumo Advanced Perfusion System 1 – Central Control Module for System 1: System 1 Base; 100/120VThe Terumo Advanced Perfusion System 1 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. Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display; loss of control functions; inability to distinguish various status; alert; alarm conditions; the inability to operate the touch screen; or the CCM
Terumo Cardiovascular Systems Corporation Jul-06-2012 Terumo Advanced Perfusion System 1 – Central Control Module for System 1: System 1 Base; 220/240VThe Terumo Advanced Perfusion System 1 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. Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display; loss of control functions; inability to distinguish various status; alert; alarm conditions; the inability to operate the touch screen; or the CCM
Philips Healthcare Inc. Jul-05-2012 Philips Xcelera Connect – Philips Xcelera Connect; Software R2.1 L 1 SP2; an interface engine for data exchange.Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS); Imaging Modalities; Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information; schedules; textual information and text reports. Xcelera Connect R2.1 L 1 SP2 ; incomplete information arriving from unformatted reports interface
DePuy Mitek; Inc.; a Johnson & Johnson Co. Jul-03-2012 Depuy Spine Side Fire Needles – Depuy Spine Side Fire Needles 11G X 4IN; part of the Confidence Spinal Cement SystemProduct Code: 283904411.The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Greiner Bio-One North America; Inc. Jul-03-2012 Vacuette Quickshield Complete Plus – Vacuette Quickshield Complete Plus; 21G x 1 (0.8 x 25 mm); Greiner bio-one.The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use. : The Quickshield Complete Plus may have a defect (split at the base); which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable.
DePuy Mitek; Inc.; a Johnson & Johnson Co. Jul-03-2012 Depuy Spine Side Fire Needles – Depuy Spine Side Fire Needles 13G X 6IN; part of the Confidence Spinal Cement SystemProduct Code 283904613.The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
DePuy Mitek; Inc.; a Johnson & Johnson Co. Jul-03-2012 Depuy Spine Side Fire Needles – Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle; part of the Confidence Spinal Cement System Product Code 283904611.The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
DePuy Mitek; Inc.; a Johnson & Johnson Co. Jul-03-2012 Depuy Spine Side Fire Needles – Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle; part of the Confidence Spinal Cement SystemProduct Code 283904413.The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Aesculap Implant Systems LLC Jul-03-2012 Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R) – S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery. Aesculap Implant Systems; LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
Pride Mobility Products Corp Jul-03-2012 Victory 9 with Power Seat – Victory 9 with Power Seat (SC609PS)Motorized wheelchair with elevating seat. The main harness connector was manufactured without the required back shield sealing protection. As a result; there is the potential for water to seep through the nonconforming harness.
Zimmer; Inc. Jul-03-2012 PathFinder NXT Pivoting Percutaneous Rod Holder – PathFinder NXT Pivoting Percutaneous Rod HolderThis device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion; positioning; and orientation through the extender sleeves; under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod; the holder is removed from the rod end by loosening the captive set screw with the set screw driver. Complaints have been reported where; during surgery; the surgeon was unable to loosen orremove the inserted rod from the rod holder instrument. The complaint investigation showedthe hex mating feature of the set screw was broken and material missing. There were noreports of fragments of the set screw being left in the patient or that there was any patient oruser injury; but these events we
Microbiologics Inc Jul-03-2012 KWIK-QC Gram Stain Slides – Microbiologics 217 Osseo Avenue North; St. Cloud; MN 56303; Gram Stain Control Slides; SLO3-10; ATCC Licensed Derivative; MediMart Europe; 11 rue Emile; Zola B.P. 2332; 38933 Grenoble Cedex 2 France.They are microscope slide preparations contains specific organisms populations of known and predictable characteristics. These slide support formal quality assurance programs by serving as quality control challenges to demonstrate and document satisfactory performance of staining regents and methods used in staining procedures and to document personnel’s ability to perform the procedure and to properly interpret the microscopic test results. Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the slide; which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could potentially lead to misdiagnosis and improper treatment of a patient.
Thayer Medical Corporation Jul-02-2012 MDI Dispenser /Adapter – AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile; single-use item; intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit; for whom aerosol medication has been prescribed; in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve; and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification; oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit; according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication; the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed; caps the MiniSpacer device; and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile. Internal data identified a molding defect in the 15 mm O.D. / I.D. MiniSpacer meter dose inhaler (MDI) adapter that results in an incomplete fill of the aerosol dispensing pathway.
