Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Roche Diagnostics Operations; Inc. Apr-11-2012 Troponin I STAT Immunoassay – Elecsys Troponin I STAT ImmunoassayFor the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction. An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case; Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots.The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the
Roche Diagnostics Operations; Inc. Apr-11-2012 Troponin I Immunoassay – Elecsys Troponin I ImmunoassayFor the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction. An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case; Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots.The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the
Class II recalls
Abbott Laboratories Inc. Apr-16-2012 Clinical Chemistry Total Bilirubin – Clinical Chemistry Total Bilirubin; 6L45-20 & 6L45-40.Used for the quantitative analysis of total bilirubin in human serum or plasma of adults and neonates. A neonatal sample that was analyzed; produced results with values that were incorrectly less than the expected limit.
Abbott Laboratories Inc. Apr-18-2012 Abbott Clinical Chemistry Albumin BCG (AlbG) – Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21Clinical Chemistry Albumin BCG 510(k) K981758; Product Code CIXThe Albumin BCG assay is used for the quantitation of albumin in human serum or plasma Observed particulate matter in some reagent cartridges.
Abbott Laboratories Inc. Apr-23-2012 ARCHITECT/AEROSET Activated Aspartate Aminotransferase – ARCHITECT/AEROSET Activated Aspartate AminotransferaseThe Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma This letter is to inform you that some samples may generate A-AST results of less than (<) 5 U/L or results within the reference range when actual concentration exceeds the non-Flex linearity of 1985 U/L. In other cases the following errors may be generated.-ARCHITECT cSystems: Error Code 1053 (Unable to calculate result; rate reaction linearity failure)-AEROSET: RL% Error CodeRevised P
Acumed LLC Apr-02-2012 The Polarus Plus Humeral Rod – The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro; OR 97124 USA***" The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
Advanced Bionics Corporation Apr-19-2012 The Precision Spinal Cord Stimulator System – OMG (Observational Mechanical Gateway) Connector – A Model Number SC-9305The Precision Spinal Cord Stimulator System 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 following: failed back surgery syndrome; intractable low back pain and leg pain. The Precision System includes an implantable l6-output; multi-channel stimulator (lPO – Implantable Pulse Generator) with a rechargeable battery power source. The lPG; commonly implanted in the abdomen or buttock area; can be configured to accept one or two leads. The leads are implanted in the epidural space; adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals. The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
Aesculap Implant Systems Apr-25-2012 Quintex Cervical Plating System – Screws – Quintex Cervical Plating System – Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: semi-constrained; constrained; and dynamic. The screws all have a head diameter of 4.0mm and vary in length from 10mm to 22mm. Rescue screws are also available with a 4.5mm head diameter and lengths of 11-19mm. The firm has received complaints that the locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
Alere San Diego Apr-26-2012 Alere Triage Profiler SOB Panel – Alere Triage Profiler SOB Panel; PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury); an aid in the diagnosis and assessment of severity of heart failure; an aid in the risk stratification of patients with heart failure; an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes. Alere San Diego; Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP; Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300; Lot W48990. Alere San Diego; Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
Alere San Diego Apr-26-2012 Alere Triage CardioProfiler Panel – Alere Triage CardioProfiler Panel; PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury); an aid in the diagnosis and assessment of severity of congestive heart failure; an aid in the risk stratification of patients with heart failure; and as an aid in the risk stratification of patients with acute coronary syndromes. Alere San Diego; Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP; Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300; Lot W48990. Alere San Diego; Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
Alere San Diego dba Biosite Innovacon Hemosense Inc Apr-20-2012 Triage TOX Drug Screen (MTD) Panel – Triage TOX Drug Screen (MTD) Panel; Model # 94400.Type of Packaging: 25 individually pouched devices in a labeled kit box.The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care 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. The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
Animas Corporation Apr-06-2012 OneTouch(R) Ping(R) Insulin Pump glucose management system – OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29; 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29; 2012 are not affected by this issue.
Baxa Corporation Apr-05-2012 Exacta-Mix 2400 Compounder (EM 2400) – The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration.Pharmacy compounding system for mixing ingredients for intravascular administration. Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
Baxa Corporation Apr-09-2012 Exacta-Mix 2400(EM2400) Compounder Operating Ststem – Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities.Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
Baxa Corporation Apr-13-2012 Baxa EVA TPN bags – Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags; Exacta Mix Dual-Chamber EVA Halobag; and Baxa Calibration Bags. Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.
Beckman Coulter Inc. Apr-06-2012 Access Immunoassay Systems – Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems.Part Number: A54378; UniCel DxC 600i APF; Part Number: A54379; UniCel DxC 600i AAF.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentration found in human body fluids. The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Beckman Coulter Inc. Apr-06-2012 Access Immunoassay Systems – Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725.Part Number: A54376; Synchron LXi 725 APF; Part Number: A54377; Synchron LXi 725 AAF.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentration found in human body fluids. The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Beckman Coulter Inc. Apr-06-2012 Access Immunoassay Systems – Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2.Part Number: A15518; Access 2 APF Wash Buffer REF 81907; Part Number: A45142; Access 2 APF Wash Buffer II REF A16792.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentration found in human body fluids. The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Beckman Coulter Inc. Apr-06-2012 Access Immunoassay Systems – Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access.Part Number: A19889; Access APF Wash Buffer REF 81907; Part Number: A45144; Access APF Wash Buffer II REF A16792.The Access Immunoassay System is an in vitro diagnostic device used for the quantitative; semi-quantitative or qualitative determination of various analyte concentration found in human body fluids. The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Beckman Coulter Inc. Apr-16-2012 Beckman Coulter Synchron Ammonia (AMM) Reagent – SYNCHRON Ammonia (AMM) ReagentProduct Usage:AMM reagent; when used in conjunction with SYNCHRON LX System(s); UniCel DxC 600/800 System(s) and SYNCHRON Systems Ammonia Calibrators; is intended for the quantitative determination of Ammonia concentration in human plasma. The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.
Biocare Medical Llc Apr-10-2012 Vina Green(tm) Chromogen Kit – BioCare Medical Vina Green Chromogen Kit; 25 mL; 100ml IVD. Kits include: Vina Green Chromogen 1. 0 mL; Vina Green Buffer; 25 mL and Vina Green Dropper Bottle. BioCare Medical; Concord; CA 94520.Vina Green is intended for both IHC and ISH applications including HPV; CMV; EBV; Kappa; TTF-1; Ki-67 and other targets/antigens such as blood and lymphatic vessels and basal and myoepithelial cells. Reports of sporadic failure of specific lots of Vina Green Chromogen Kit; either through crystal formation that obscures positive staining; color not right; or a complete fading of staining by the chromogen.
Biomet 3i; LLC Apr-25-2012 Certain Low-Profile; Angled Abutment – Certain Low-Profile; Angled Abutment; Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive ; Palm Beach Gardens; FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***".Intended to provide a means to attach crown restorations or implant frameworks to implants. Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
Biomet; Inc. Apr-19-2012 Optilock; Locking Screw 3.5mm x 28mm – Optilock; Locking Screw 3.5 mm x 28 mm; non sterile; REF 37728; Biomet Trauma Parsippany; NJ 97054.Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system. Biomet initiated this action after a complaint was received that item 36728; Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728; Locking Screw 3.5mm x 28mm.
Biomet; Inc. Apr-19-2012 MAK OSS No Head Lock Pin – REF. CP113456; MAK OSS No Head Lock Pin; NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPESTERILE; R; Biomet Orthopedics Warsaw; IN 46581.The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly. Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodgingfrom its intended position (post-initial surgery). An investigation was initiated and the available lots ofthe Lock Pin were evaluated and measured against print specifications.
Biomet; Inc. Apr-23-2012 Selex M2A Magnum Modular Head; 40 mm – Ref; S331140 Selex M2A Magnum Modular Head; 40 mm head diameter plus 3 mm neck;1 Taper; Sterile; Biomet Orthopedics; Warsaw; IN Product Usage:Intended for use in non-cemented primary and revision hip joint replacement Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.
Boston Scientific Corporation Apr-11-2012 "Boston Scientific; IMAGER II Angiographic Catheter; – Boston Scientific; IMAGER II Angiographic Catheter; Sterilized with ethylene oxide gas. Made in Ireland; Manufactured for Boston Scientific Corporation; One Boston Scientific Place; Natick; MA 01760-1537.The following product is being recalled: ""Material Number/(OUTER CARTON LABEL OF 5pk)""/""Material Number(INNER-POUCH LABEL FOR EACH SINGLE CATHETER)"" / Material Description / Catalog Number.M001314001 M001314000 IMAGER II/5/ST/65/038 BX5 31-400M001314011 M001314010 IMAGER II/5/ST/100/038 BX5 31-401M001314021 M001314020 IMAGER II/5/ST/65/035 BX 5 31-402M001314031 M001314030 IMAGER II/5/ST/100/035 BX 5 31-403M001314041 M001314040 IMAGER II/5/BARNH/100/038 BX5 31-404M001314051 M001314050 IMAGER II/5/BERN/100/038 BX5 31-405M001314061 M001314060 IMAGER II/5/BERN/100/035 BX 5 31-406M001314071 M001314070 IMAGER II/5/BERN/40/035 BX 5 31-407M001314081 M001314080 IMAGER II/5/BERN/40/038 BX5 31-408M001314091 M001314090 IMAGER II/5/BERN/65/035 BX 5 31-409M001314101 M001314100 IMAGER II/5/BERN/65/038 BX5 31-410M001314111 M001314110 IMAGER II/5/WEIN/100/038 BX5 31-411M001314121 M001314120 IMAGER II/5/WEIN/100/035 BX 5 31-412M001314131 M001314130 IMAGER II/5/H1/65/038 BX5 31-413M001314141 M001314140 IMAGER II/5/H1/100/038 BX5 31-414M001314151 M001314150 IMAGER II/5/H1/100/035 BX 5 31-415M001314161 M001314160 IMAGER II/5/H3/100/038 BX5 31-416M001314171 M001314170 IMAGER II/5/H3/100/035 BX 5 31-417M001314181 M001314180 IMAGER II/5/H1H/100/038 BX5 31-418M001314191 M001314190 IMAGER II/5/H1H/100/035 BX 5 31-419M001314201 M001314200 IMAGER II/5/H3H/100/035 BX 5 31-420M001314211 M001314210 IMAGER II/5/JB1/65/038 BX5 31-421M001314221 M001314220 IMAGER II/5/JB1/100/038 BX5 31-422M001314231 M001314230 IMAGER II/5/JB1/100/035 BX 5 31-423M001314241 M001314240 IMAGER II/5/JB2/100/038 BX5 31-424M001314251 M001314250 IMAGER II/5/JB2/100/035 BX 5 31-425M001314261 M001314260 IMAGER II/5/JB3/100/038 BX5 31-426M001314271 M001314270 IMAGER II/5/JB3/100/035 BX 5 31-427M001314281 M001314280 IMAGER II/5/MAN/100/038 BX5 31-428M001314291 M001314290 IMAGER II/5/MAN/100/035 BX 5 31-429M001314301 M001314300 IMAGER II/5/SIM1/65/038 BX5 31-430M001314311 M001314310 IMAGER II/5/SIM1/65/035 BX 5 31-431M001314321 M001314320 IMAGER II/5/SIM1/100/038 BX5 31-432M001314331 M001314330 IMAGER II/5/SIM1/100/035 BX 5 31-433M001314341 M001314340 IMAGER II/5/SIM2/100/038 BX5 31-434M001314351 M001314350 IMAGER II/5/SIM2/100/035 BX 5 31-435M001314361 M001314360 IMAGER II/5/SIM3/100/038 BX5 31-436M001314371 M001314370 IMAGER II/5/SIM3/100/035 BX 5 31-437M001314381 M001314380 IMAGER II/5/SIM4/100/038 BX5 31-438M001314391 M001314390 IMAGER II/5/HN1/100/038 BX5 31-439M001314401 M001314400 IMAGER II/5/HN1/100/035 BX 5 31-440M001314411 M001314410 IMAGER II/5/HN2/100/038 BX5 31-441M001314421 M001314420 IMAGER II/5/HN2/100/035 BX 5 31-442M001314431 M001314430 IMAGER II/5/HN3/100/038 BX5 31-443M001314441 M001314440 IMAGER II/5/HN3/100/035 BX 5 31-444M001314451 M001314450 IMAGER II/5/HN4/100/038 BX5 31-445M001314461 M001314460 IMAGER II/5/HN4/100/035 BX 5 31-446M001314471 M001314470 IMAGER II/5/HN5/100/038 BX5 31-447M001314481 M001314480 IMAGER II/5/HN5/100/035 BX 5 31-448M001314491 M001314490 IMAGER II/5/CK/100/035 BX 5 31-449M001314501 M001314500 IMAGER II/5/GEN/100/035 BX 5 31-450M001314511 M001314510 IMAGER II/5/GEN+2 SIDEHOLES/100/035 BX 5 31-451M001314521 M001314520 IMAGER II/5/CHGB/65/038 BX5 31-452M001314531 M001314530 IMAGER II/5/CHGB/65/035 BX 5 31-453M001314541 M001314540 IMAGER II/5/CHGC/65/038 BX5 31-454M001314551 M001314550 IMAGER II/5/CHGC/65/035 BX 5 31-455M001314561 M001314560 IMAGER II/5/CHG2.5/65/038 BX5 31-456M001314571 M001314570 IMAGER II/5/CHG2.5/65/035 BX 5 31-457M001314581 M001314580 IMAGER II/5/CONTRA 2/65/038 BX5 31-458M001314591 M001314590 IMAGER II/5/CONTRA 2/65/035 BX 5 31-459M001314611 M001314610 IMAGER II/5/DUCK/65/035 BX 5 31-4" Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigationhas found that; during shipping; some units in the 5-pack box may experience a physical interaction between the carton and the area onthe pouch where the hub is located. This interaction was found to cause pi
Boston Scientific Corporation Apr-11-2012 Boston Scientific; IMAGER II Urology Torque Catheter – Boston Scientific; IMAGER II Urology Torque Catheter; Sterilized with ethylene oxide gas. Made in Ireland; Manufactured for Boston Scientific Corporation; One Boston Scientific Place; Natick; MA 01760-1537.The following products being recalled: Imager" II Catheters C1 5fr 65cmM0064003001 M0064003000400-300Imager" II Catheters C2 5fr 65cmM0064003011 M0064003010Catalog # 400-301Imager" II Catheters Straight 5fr 65cmM0064003021 M0064003020Catalog #400-302Imager" II Catheters Bern 5fr 65cmM0064003031 M0064003030Catalog #400-303Imager" II Catheters JB1 5fr 65cmM0064003041 M0064003040Catalog #400-304Imager" II Catheters Straight 5fr 100cmM0064004021 M0064004020Catalog #400-402Imager" II Catheters Bern 5fr 100cmM0064004031 M0064004030Catalog #400-403Imager" II Catheters JB1 5fr 100cmM0064004041 M0064004040Catalog #400-404Imager" II Catheters Bern 5fr 40cmM0064005031 M0064005030Catalog #400-503The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract; either through a retrograde or antegrade route; and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels; such as BackStop"; intended for use in the urinary tract. Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigationhas found that; during shipping; some units in the 5-pack box may experience a physical interaction between the carton and the area onthe pouch where the hub is located. This interaction was found to cause pi
Boston Scientific CRM Corp Apr-20-2012 Latitude Patient Management System Communicator – Boston Scientific LATITUDE¿ Patient Management System Communicator; Model 6476; Distributed by Boston Scientific; 4100 Hamline Avenue North; St. Paul; MN 55112-5798; Made in Malaysia. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. Boston Scientific LATITUDE? Patient Management System Communicators were shipped to the incorrect patients.
Computerized Medical Systems Inc Apr-03-2012 Monaco – Monaco Radiation Treatment Planning System; Version 3.10.00.Planning of radiation therapy. An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
DePuy Orthopaedics; Inc. Apr-16-2012 PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) – PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit)The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made. Sterility of the pins is at risk because product packaging; which is designed to include 2 pouches ( innerpouch and ourter pouch) around the pin mounting card only; contains a single pouch; which could compromise product sterility.
DePuy Orthopaedics; Inc. Apr-16-2012 DePuy Attune Impaction Handle Warsaw – DePuy Attune Impaction Handle Warsaw; IN 46582Packaging: Product is packed within a polyethylene bag; with protection added as needed for sharp and/or fragile points.Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact; insert; and extract various Attune Instruments. The handle interfaces with the Keel Punch; Tibial Tower; Evaluation Bullet; Fixed Bearing Tibial Impactor; Rotating Platform Tibial Impactor and the Femoral Impactor. DePuy Orthopaedics; Inc. is issuing a Recall Notice for nine lots of the Attune" Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is designed specifically for the installation of the Attune Knee
DeRoyal Industries Inc Apr-12-2012 Umbilicup – DeRoyal (R) Umbilicup; REF 72-8000; Rx Only; STERILE EO; Manufactured by DeRoyal; Powell; TN 37849Product Usage: Collection of cord blood Device’s needle may become dislodged from the cup during shipment or during use.
DeRoyal Industries Inc Apr-12-2012 Umbilicup – DeRoyal (R) Umbilicup; REF 72-8000NS; Rx Only; Manufactured by DeRoyal; Powell; TN 37849Product Usage: Collection of cord blood Device’s needle may become dislodged from the cup during shipment or during use.
DeRoyal Industries Inc Apr-12-2012 Umbilicup – Sterile surgical kits containing the Umbilicup device:DeRoyal (R) VAGINAL DELIVERY PACK; REF 89-5260.04; Rx Only; STERILE EO; Manufacturer: DeRoyal; Powell; TN 37849DeRoyal (R) VAGINAL DELIVERY TRAY; REF 89-3928.10; Rx Only; STERILE EO; Manufacturer: DeRoyal; Powell; TN 37849DeRoyal (R) C-SECTION TRAY; REF 89-2960.20; Rx Only; STERILE EO; Manufacturer: DeRoyal; Powell; TN 37849Product Usage: Collection of cord blood Device’s needle may become dislodged from the cup during shipment or during use.
Fresenius Medical Care Holdings; Inc. Apr-24-2012 Fresenius Liberty Cycler – Fresenius Liberty Cycler Software; User Manuals; and Handi-Guides for acute and chronic peritoneal dialysis. Software versions earlier than 2.8.The Fresenius Liberty Cycler is intended for acute or chronic peritoneal dialysis. Increased risk of intraperitoneal volume (IIPV); referred to as Overfill
GE Healthcare; LLC Apr-24-2012 GE Automatic Mobile X-Ray Systems – GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW; Brivo XR285 30KW; Optima XR200 15KW; Optima XR200 30KW; Optima XR220 15KW; and Optima XR220 30KW.General Electric; Waukesha; WI Indicated for taking radiographic exposures of the skull; spinal column; chest; abdomen; extremities; and other body parts with the patient sitting; standing; or lying in the prone or supine position. GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product; related to the light field to x-ray field edge alignment.
Gendex Dental Systems Apr-02-2012 Gendex eXpert DC Intraoral Dental X-Ray System – Gendex eXpert DC Intraoral Dental X-Ray SystemDevice is to be used as an extra-oral source of X-Rays in Dental Radiography Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.
Hologic; Inc. Apr-05-2012 Hologics SecurView DX workstation – Hologics SecurView DX workstation; software version 7.3.0 intended for viewing mammography images and other imaging modalities.SecurView DX is intended for selection; display; manipulation; filing and media interchange of multimodality images from a variety of different modality systems. It also interfaces to various image storage and printing devices; using DICOM or similar interface standards. The device used with FDA-cleared monitors may be used by a trained physician for display; manipulation; and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography; as well as any other DICOM multimodality image. SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images
Hospira Inc. Apr-26-2012 GemStar Bolus Cord – GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps; list 13000; 13150; 13087 and 13088; Hospira; Inc.; Lake Forest; IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump. Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial Apr-18-2012 MEDPOR PLUS – MEDPOR PLUS SST EZ 22mm Sphere Implant; Howmedica Osteonics Corp; 15 Dart Road; Newnan; GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe. The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8; therefore implant is not easily released from the syringe.
Integra LifeSciences Corp. Apr-16-2012 Panta Arthrodesis Nail – Panta¿ Arthrodesis Nail Support device; 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws; two (2) calcaneal screws and one (optional) talar screw. The nail; cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3; ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta¿ Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus; cerebral vascular accident; paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint. The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.
KCI USA; Inc. Apr-16-2012 Zuma Mobility System – Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01.Product Usage: Human Non-AC-Powered Patient Lift The Zuma Mobility Assist and Trainer have the potential to bind during lowering operation.
Leica Microsystems; Inc. Apr-27-2012 ASP 6025 Vacuum Tissue Processor – ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH; Heidelberger Str. 17-19; D-69226 Nussloch; Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation; dehydration; and infiltration. There is a potential malfunction with the device in autorotation mode; which can lead to incorrect reagent handling of the device. The end result may lead to damage or to loss of tissue specimens.
Lifescan Inc Apr-02-2012 OneTouch Verio IQ Blood Glucose Monitoring System Kit; – OneTouch Verio IQ Blood Glucose Monitoring System Kit;One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit;One Touch Verio IQ Blood Glucose Monitoring Warranty Kit.Distributed by : LifeScan; Inc.Milpitas; CA 95035for: LifeScan EuropeDivision of Cilag GmBH International6300 ZugSwitzerlandMeter made in China.Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display.
Maquet Inc. Apr-03-2012 Servo-i ventilator system – Servo-i ventilator systemProduct Usage: Intended for treatment and monitoring of patients in the range of neonates; infants and adults with respiratory failure or respiratory insufficiency. The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
Maquet Inc. Apr-03-2012 Servo-i ventilator system – Servo-s ventilator systemProduct Usage: Intended for treatment and monitoring of patients in the range of neonates; infants and adults with respiratory failure or respiratory insufficiency. The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
Medical Information Technology; Inc. Apr-26-2012 MEDITECH Anatomical Pathology Software – MEDITECH Anatomical Pathology Software Client Releases-Client Service Releases 5.6; 5.63; 5.64; 5.65; 6.0; 6.04; 6.05; 6.06; 6.1; 6.12 and 6.13Product Usage:Meditech Anatomical Pathology Software records; stores; codes; searches and provides reports for pathology cases. It enables pathology staff and other personnel to access related findings in real time. Meditech Anatomical Pathology software is being recalled because data on a pathology specimen may be inadvertently deleted.
Medtronic Sofamor Danek USA Inc Apr-19-2012 adjustable drill stop – PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop; REF 6905712; QTY: 1 EA; Rx only; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132Product Usage:Manual orthopedic adjustable drill stop Drill stops may be bypassed when the device is used with powered drilling instruments.
Medtronic Sofamor Danek USA Inc Apr-19-2012 adjustable drill stop – ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop; REF 876-460; QTY: 1 EA; Rx only; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132Product Usage:Manual orthopedic adjustable drill stop Drill stops may be bypassed when the device is used with powered drilling instruments.
Medtronic Sofamor Danek USA Inc Apr-19-2012 adjustable drill stop – VERTEX MAX (R) Cannulated; VERTEX MAX (R); and VERTEX (R) Reconstruction System Adjustable Drill Stop; REF 6860460; QTY: 1 EA; Rx only; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132Product Usage:Manual orthopedic adjustable drill stop Drill stops may be bypassed when the device is used with powered drilling instruments.
Milabs Bv Apr-05-2012 U-SPECT-II/CT and VECTor/CT cabinet x-ray products – U-SPECT-II/CT and VECTor/CT cabinet x-ray products.Laboratory research using small animals. These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally; these products do not have a certification label and the identification labels do not include the month and year of manufacture.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike and Y-Site with Checked Valve Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Female Luer Adapter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Epidural Administration Set with 150 mL Bag and 0.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter and Check Valve Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron FilterThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Curlin administration set with vented spike; 0.2 micron filter; and check valveThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Female Male Luer Locks and Y-Site with Check Valve Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Epidural Yellow Striped Tubing Administration Set with Vented Vial Spike and 0.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Epidural Administration Set with 0.2 Micron Filter Non-Vented Bag Spike ASV Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-Vented Bag Spike; Microbore tubing w/free-flow protection; slide clamp ASVThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Needleless Injection Port Positive Pressure Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
MOOG Medical Devices Group Apr-13-2012 Curlin Infusion Administration Set – Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter ASV Packaged AssemblyThe Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories; provide a means for the volumetric delivery of fluids used in Parenteral; Enteral; Epidural; Subcutaneous and Intravenous applications. Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump; 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
North Coast Medical Inc Apr-16-2012 Norco Folding Shower Bench – Norco Folding Shower Bench;Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs.North Coast Medical Inc.8100 Camino ArroyoGilroy; CA 95020Comfort and safety in shower Due to a consumer complaint; North Coast Medical determined that due to a design flaw; there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs.
Ortho-Clinical Diagnostics Apr-26-2012 VITROS – VITROS¿ 3600 Immunodiagnostic SystemProduct Usage:For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Immunodiagnostic Products Reagents. Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Ortho-Clinical Diagnostics Apr-26-2012 VITROS – VITROS¿ 5600 Chemistry System; Product Code: 6802413 Product Usage:For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Ortho-Clinical Diagnostics Apr-26-2012 VITROS – VITROS¿ 4600 Chemistry System; Product Code: 6802445 Product Usage:For use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Ortho-Clinical Diagnostics Apr-26-2012 VITROS – VITROS¿ 5;1 FS Refurbished System; Product Codes: 6801375 & 6801890Product Usage:For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Ortho-Clinical Diagnostics Apr-26-2012 VITROS – VITROS¿ 5;1 FS System; Product Codes: 6801375 & 6801890Product Usage:For use in the in vitro quantitative; semi-quantitative; and qualitative measurement of a variety of analytes of clinical interest; using VITROS Chemistry Products Slides; VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
Philips Healthcare Inc. Apr-25-2012 Allura X-ray system – Allura X-ray System.The Allura X-ray System is an angiographic X-ray system. The monitor Ceiling suspension may fail; which may cause the monitor to drop.
Philips Healthcare Inc. Apr-26-2012 Digital Diagnost – Philips Digital Diagnost Systems with Eleva software version 2.x and stitching optionIntended use: Stationary radiographic system; Radiographic system; digital Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling
Philips Medical Systems (Cleveland) Inc Apr-02-2012 Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems – Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model# 728231; Ingenuity CT Model # 728326; Distributed By: Philips Healthcare; Cleveland; OH.The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied; the scan increment changes from the user defined values (noncontiguous) to a contiguous scan.
Philips Medical Systems (Cleveland) Inc Apr-05-2012 Brilliance Big Bore Computed Tomography X-Ray Systems – Brilliance Big Bore Computed Tomography X-Ray Systems; M/N 728243; 728244; Distributed by: Philips Medical System; Cleveland; OHProduct Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. The detection; localization; and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode; and the software does not force the user to exit the edit mode before saving. In TumorLOC; when saving while a contour is in edit mode; that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.
Philips Medical Systems (Cleveland) Inc Apr-05-2012 Extended Brilliance Workstation Computed Tomography X-Ray Systems – Extended Brilliance Workstation Computed Tomography X-Ray Systems; M/N 728260; Distributed by: Philips Medical System; Cleveland; OHProduct Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. The detection; localization; and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode; and the software does not force the user to exit the edit mode before saving. In TumorLOC; when saving while a contour is in edit mode; that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.
Philips Medical Systems (Cleveland) Inc Apr-05-2012 GEMINI GXL 6; 10 & 16 Computed Tomography X-Ray Systems; – GEMINI GXL 6; 10 & 16 Computed Tomography X-Ray Systems; M/N 882390; 882400 & 882410; Distributed by: Philips Medical System; Cleveland; OHProduct Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. The detection; localization; and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode; and the software does not force the user to exit the edit mode before saving. In TumorLOC; when saving while a contour is in edit mode; that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.
Philips Medical Systems (Cleveland) Inc Apr-05-2012 GEMINI TF 16; 64 & Big Bore Computed Tomography X-Ray Systems – GEMINI TF 16; 64 & Big Bore Computed Tomography X-Ray Systems; M/N 882470; 882471 & 882476; Distributed by: Philips Medical System; Cleveland; OHProduct Usage: The Computed Tomography X-Ray Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Image processing and display workstations provide software applications to process; analyze; display; quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a fused (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation; detection and diagnosis of lesions; disease and organ function such as but not limited to cancer; cardiovascular disease; and neurological disorders. The detection; localization; and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional; diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode; and the software does not force the user to exit the edit mode before saving. In TumorLOC; when saving while a contour is in edit mode; that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list.
Roche Diagnostics Operations; Inc. Apr-09-2012 ACCU-CHEK Aviva Nano Blood Glucose Meter – ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling; beyond the labels applied to the meter; was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached.The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The system is intended to be used by a single person and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. These meters were not intended for distribution; were not verified to meet final product specifications and were not distributed to customers with the necessary pr
Scottcare Corporation Apr-13-2012 TeleSentry; Multi-parameter Ambulatory Telemetry – TeleSentry; Multi-parameter Ambulatory Telemetry; Model #TS01. Dist. By: ScottCare Corporation; Cleveland; OH.The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data; automatically records events triggered by an arrhythmia detection algorithm or manually by the patient; and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad; the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning.
Sendx Medical Inc Apr-09-2012 SenDx Medical Inc. ABL80FLEX – SenDx Medical IncABL80FLEXBlood Gas; pH; Electrolyte; and Metabolite SystemThe ABL80 FLEX is a portable; automated analyzer that measures pH; blood gases; electrolytes; glucose; and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists; nurses; physicians and therapists. It is intended for use in a laboratory environment; near patient or point-of-care setting. The product can cause the analyzer to report values outside the published performance specifications for pH; pCO2; cNa+; cK+; cCa2+ and cCl-.
Siemens Healthcare Diagnostics; Inc Apr-09-2012 ADVIA Centaur Cortisol Assay – Siemens ADVIA Centaur Cortisol AssayCat. Nos.04610138 (1 0321 026)- 250 Test kit04610049(10309078)- 50 Test kit04611509 (1 0335503)- 250 REF Test kitADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems. Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
Siemens Healthcare Diagnostics; Inc. Apr-10-2012 EasyLink(TM) Informatics Systems – EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System.The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System; and may be used with other Siemens analyzers; as a communications and connectivity workstation for integration with laboratory information system (LIS) networks. Product Quantity Distributed (Int) 787 QC results may be unexpectedly associated with a Pending Control. When this situation occurs; Pending QC Controls maybe be created or reused.
Siemens Healthcare Diagnostics; Inc. Apr-17-2012 Dimension Vista(R) MG Flex(R) Reagent Cartridge – Dimension Vista(R) MG Flex(R) Reagent CartridgeThe Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum; plasma and urine on the Dimension Vista(R) System Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium
Siemens Healthcare Diagnostics; Inc. Apr-25-2012 Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 – Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting; mixing; heating; and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric; turbidimetric; chemiluminescence; nephelometric and integrated ion-selective multisensory technology for clinical use. Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations
Siemens Medical Solutions USA; Inc Apr-02-2012 Siemens MAGNETOM Verio – Siemens MAGNETOM VerioUse: Nuclear resonance imaging system During product monitoring; Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated; leading to the emission of smoke and possible material damage.
Siemens Medical Solutions USA; Inc Apr-09-2012 Siemens Axiom Luminos dRF solid state x-ray imager – Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager) During regular product monitoring; Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches – during a regular scheduled calibration of the wrench; it was discovered that the wrench was out of the specification. The wrench was over-torquing approximately 21% for low-end readings (50 ftlbs) and 9% for high-end readings (250
Spectranetics Corp. Apr-11-2012 12Fr SLS II Laser Sheath – 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation. Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
Spinetronics; LLC Apr-02-2012 Antalgic-Trak Literature – Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By Spinetronics***Note: "Decompression" as used herein refers to unloading due to distraction and positioning.***Antalgic-Trak is an improved form of non-surgical spinal decompression*. On 08/11/2011 Spinetronics; LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k; and represented a major change or modification in the intended use of the device.
Stanley Security Solutions; Inc. Apr-27-2012 UMP Personal Sentry Deluxe Pull String Monitor; Model #91650. – UMP Personal Sentry Deluxe Pull String Monitor; Model #91650. The firm on the label is Universal Medical Products; Lincoln; NE. Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair; chair; or bed. Monitor gives false alarms
Stanley Security Solutions; Inc. Apr-28-2012 Micro-Tech Informer Plus Silver Monitors – Micro-Tech Informer Plus Silver Monitor; Model 81830. The firm name on the label is Stanley Security Solutions; Inc.; Lincoln; NE.Product Usage:The system is a bed exit system designed to indicate; by alarm or signal; when someone attempts to leave the bed. The system consists of a control unit that is mounted on the bed and a pressure sensitive bed sensor pad that is placed across the width of the bed under the mattress or just beneath the sheets and overlays. The control unit is powered by means of a plug-in type power supply and an alarm cord is used to interface the control unit with the nurse call system. Connection between the call cord and the receptacle may not make a correct connection resulting in a continuous or intermittent (false) signal to the nurse call system
Synaptic Corp Apr-19-2012 Synaptic – Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA; Aurora; CO.Transcutaneous nerve stimulation for pain relief and other medical treatment uses. Device was distributed without marketing approval.
Teleflex Medical Apr-16-2012 Hudson RCI – Hudson RCI; BiteGard Oral Bite Block; Single Patient Use; Rx Only; Teleflex Medical; Research Triangle Park; NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube; in the case where one is used. Teleflex Medical received complaints that the bite block can become separated from the handle. If separation occurs; medical intervention may be required to remove the bite block from the patient’s trachea or esophagus/GI tract.
Terumo Cardiovascular Systems Corporation Apr-06-2012 CDI 500 Monitor – CDI Blood Parameter Monitoring System 500; 500A.Intended for use during cardiopulmonary bypass procedures. Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Terumo Cardiovascular Systems Corporation Apr-06-2012 CDI 500 Monitor – CDI Blood Parameter Monitoring System 500; 500AV.Intended for use during cardiopulmonary bypass procedures. Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Terumo Cardiovascular Systems Corporation Apr-06-2012 CDI 500 Monitor – CDI Blood Parameter Monitoring System 500; 500AHCT.Intended for use during cardiopulmonary bypass procedures. Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Terumo Cardiovascular Systems Corporation Apr-06-2012 CDI 500 Monitor – CDI Blood Parameter Monitoring System 500; 500AVHCT.Intended for use during cardiopulmonary bypass procedures. Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Terumo Cardiovascular Systems Corporation Apr-06-2012 CDI 500 Monitor – CDI Blood Parameter Monitoring System 500; 500V.Intended for use during cardiopulmonary bypass procedures. Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
Terumo Cardiovascular Systems Corporation Apr-23-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board; Arterial Monitor (service part only)The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation; the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display; or could cause monitor reset; po
Terumo Cardiovascular Systems Corporation Apr-23-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board; Cardioplegia Monitor (service part only)The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation; the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display; or could cause monitor reset; po
Terumo Cardiovascular Systems Corporation Apr-23-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial MonitorThe 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation; the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display; or could cause monitor reset; po
Terumo Cardiovascular Systems Corporation Apr-23-2012 Sarns Modular Perfusion System 8000 – Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia MonitorThe 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation; the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display; or could cause monitor reset; po
Teva Pharmaceuticals USA; Inc. Apr-18-2012 ViaSpan Cold Storage Solution 1000mL Bag – ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags).Disposable kidney perfusion set. Lack of assurance of sterility
Varian Medical Systems; Inc. Apr-10-2012 Variseed 7.1 – VariSeed 7.1; software application; part number H62; manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures. Brachytherapy device requires the user to enter radioactive source activity; but software may specify unintended units for activity and lead to overdose in patient treatment.
Visicu; Inc. Apr-27-2012 Philips eCareManager System – Philips eCareManager System; Model 865325; software versions 3.7; 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection; storage; and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote; supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment. Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.
Winco Mfg.; LLC Apr-25-2012 Care Cliner – CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***ISO 9001-2008 Certified***Outstanding Value and Quality in Our Standard Care Cliner***Lower price does not mean lower quality when you buy a Winco Care Clinger. Our standard Care Cliner comes with all the superior features you might find on higher-priced clinical chairs.***KEY FEATURES***Standard head-rest cover***Padded armrests***Dual fold down side-tables***Removable side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala; FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"The Care Cliner is a multi position recliner with a steel frame used primarily in clinics; hospitals and treatment centers for recovery; dialysis; oncology; examination; infusion. Winco Manufacturing LLC is recalling the Care Cliner; XL Care Cliner; Drop Arm Care Cliner; Elite Care Cliner; and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster’s axle working itself out of the assembly under unconventional conditions. Should this
Winco Mfg.; LLC Apr-25-2012 Care Cliner – NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner; independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest; Winco’s Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis; oncology; acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics; hospitals and treatment centers for recovery; dialysis; oncology; examination; infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala; FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"Note: Model 6988 is a version of the 6980 without the footplate. We have a single; but high volume customer; that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request; there is not a piece of literature for it. Winco Manufacturing LLC is recalling the Care Cliner; XL Care Cliner; Drop Arm Care Cliner; Elite Care Cliner; and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster’s axle working itself out of the assembly under unconventional conditions. Should this
Winco Mfg.; LLC Apr-25-2012 Care Cliner – CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550/6570 (w/ NYLON CASTERS)***Winco ISO 9001-2008 Certified***All of our best features; plus the added versatility of drop arms***Leave it to Winco to combine the best clinical chair features in the industry with the convenience of dual drop-arms! Our drop-arm care cliners make assisting your patients easier. Our side-panels lift; making clean-ups quick and easy.***KEY FEATURES***Standard head-rest cover***Padded drop-down armrests***Dual fold down side-tables***Easy-to-clean side panels***Trendelenburg Positioning***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 334474***www.wincomfg.com***". Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala; FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"The Care Cliner is a multi position recliner with a steel frame used primarily in clinics; hospitals and treatment centers for recovery; dialysis; oncology; examination; infusion. Winco Manufacturing LLC is recalling the Care Cliner; XL Care Cliner; Drop Arm Care Cliner; Elite Care Cliner; and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster’s axle working itself out of the assembly under unconventional conditions. Should this
Winco Mfg.; LLC Apr-25-2012 Care Cliner – ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part: "***ELITE CARE CLINER 6900/6910***Winco***ISO 9001-2008 Certified***Design; comfort; durability; and value that exceed your expectations.***Attention to detail and concern for comfort and quality; standards that Winco recliners are known for; places the Elite Care Cliner among the best-selling chairs on the market today. LiquiCell; an ultra-thin liquid filled interface that aids in reducing skin pressure; is standard for the Elite Care Cliner.***HEAT MASSAGE (Optional)***KEY FEATURES***Dual fold down tables***LiquiCell for added comfort***5¿¿¿ nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 334474***www.wincomfg.com***".Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala; FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"The Care Cliner is a multi position recliner with a steel frame used primarily in clinics; hospitals and treatment centers for recovery; dialysis; oncology; examination; infusion. Winco Manufacturing LLC is recalling the Care Cliner; XL Care Cliner; Drop Arm Care Cliner; Elite Care Cliner; and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster’s axle working itself out of the assembly under unconventional conditions. Should this
Winco Mfg.; LLC Apr-25-2012 Care Cliner – ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms; allowing patients with limited mobility a modified entry. Also; LiquiCell has been added into the seat for extra comfort. This ultra-thin; liquid-filled interface aids in improved blood flow; and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala; Florida 334474***www.wincomfg.com***".Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala; FL 34474***www.wincomfg.com*** Model No. ***Serial No.***"The Care Cliner is a multi position recliner with a steel frame used primarily in clinics; hospitals and treatment centers for recovery; dialysis; oncology; examination; infusion. Winco Manufacturing LLC is recalling the Care Cliner; XL Care Cliner; Drop Arm Care Cliner; Elite Care Cliner; and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster’s axle working itself out of the assembly under unconventional conditions. Should this
Ziehm Imaging Inc Apr-16-2012 Double Foot Switch – Double foot switch; type KF 2 1S/1 S-MED-AP; manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany; and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch:Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***"Labeled in part: "Fluoro – Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***"Labeled in part: "Fluoro – Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***"Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***"Labeled in part: "DSA – CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***"Labeled in part: "Cine – Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***"Labeled in part: "Cine – LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***"Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***"Labeled in part: "Fluoro – Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***"Labeled in part: "DSA / MSA/RSA – OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***"The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch. On 04/29/2011; Ziehm Imaging; Inc.; Orlando; FL recalled the double foot switch; type KF 2 1S/1S-MED-AP; a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray as the foot switch may not become inactive when the pedal is released.