Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Animas Corporation Apr-03-2013 Animas(R) 2020 Insulin Infusion Pump – Animas(R) 2020 Insulin Infusion PumpProduct Usage:This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: – Loss of prime; -Occlusion; or -No cartridge detected.
GE Healthcare; LLC Apr-05-2013 Giraffe Omnibed and Incubator – Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel; MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer. Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure.
Engineered Medical Systems;Inc Apr-10-2013 SealFlex – Respironics SealFlex Single Port Ribbed Mask (Infant).For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.
Lifescan Inc Apr-12-2013 OneTouch Verio IQ Blood Glucose Monitoring System – All OneTouch Verio IQ Blood Glucose Meters sold as:Verio IQ System Kits – Meter;Verio IQ Starter kits – Meter;Verio IQ Warranty Meter.Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ VerioIQ Blood Glucose Monitoring 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 Verio IQ meter will shut off and revert to set up mode at glucose values above 1023 instead of displaying EXTREME HIGH GLUCOSE.
Stryker Howmedica Osteonics Corp. Apr-12-2013 ShapeMatch Cutting Guides – ShapeMatch Cutting GuidesProduct Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting. With regards to ShapeMatch Cutting Guides using MRI Imaging; Stryker Orthopaedicshas become aware that there are potential issues associated with internal processesfor planning cases and producing ShapeMatch Cutting Guides.
Carefusion Corporation Apr-15-2013 Alaris PC Unit 8015 – Alaris PC unit model 8015 with software version 9.12Product Usage: The Alaris PC unit is the central programming; monitoring and power supply component for the Alaris System. The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
Newport Medical Instruments Inc Apr-26-2013 Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries – Newport Medical Instruments HT70and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.
Maquet Cardiovascular Us Sales; Llc Apr-26-2013 SERVO-i ventilator system – Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180).Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2; NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure; ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation. When using the SERVO-i on battery power; in a very small number of cases; some battery modules distributed after January 31; 2010 have a shorter battery run time than expected.
Hospira Inc. Apr-26-2013 GemStar Infusion System – GemStar Pump – BatteryProduct Usage: The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy’s parameters and causes an 11/004 error resulting in the pump not being able to be used.
Hospira Inc. Apr-26-2013 GemStar Infusion System – GemStar Pump – BatteryProduct Usage: The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy’s parameters and causes an 11/004 error resulting in the pump not being able to be used.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Recalling Manufacturer Date Posted Trade Name/Product Reason for Recall
Integra Burlington MA; Inc. Apr-01-2013 Integra Life Sciences Ojemann Cortical Stimulator – Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2.Intended for intraoperative cortical stimulation mapping procedures. If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static electricity) comes in contact with the outer case of the unit; that voltage could be transmitted to the patient and could be a potential source of injury.
Beckman Coulter Inc. Apr-01-2013 Access Immunoassay Systems – Access 2 Immunoassay System; P/N 107405S 2/12The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield; which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Beckman Coulter Inc. Apr-01-2013 Access Immunoassay Systems – Synchron LXi 725 Clinical System; P/N 107405SProduct Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield; which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Beckman Coulter Inc. Apr-01-2013 Access Immunoassay Systems – UniCel DxC 600i Synchron Access Clinical System; P/N 107405SProduct Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield; which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Philips Medical Systems (Cleveland) Inc Apr-01-2013 Ingenuity TF PET/CT – Ingenuity TF PET/CT.Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur; could cause a risk for patients; users or service personnel; including inaccurate standard uptake values (SUV). Philips Medical Systems (Cleveland); Inc. is issuing a software update to address the issues.
Zimmer; Inc. Apr-01-2013 NexPosure Portal System – Zimmer NexPosure; retractor portals of the NexPosure MIS Access System; Part Numbers or REF numbers: N1830R80-100; N1830R80-090¿; N1830R80-080¿; N1830R80-070¿; N1830R80-060; N1830R50-100; N1830R50-090; N1830R50-080; ¿ N1830R50-070; N1830R50-060; N1830L80-100; N1830L80-090; N1830L80-080; N1830L80-070; N1830L80-060; N1830L50-100; N1830L50-090; N1830L50-080; N1830L50-070; N1830L50-060; ¿ N182450-085; N182450-075; N182450-065; N182450-055; N182450-045.¿ Retractor access system that allows placement of posterior spinal fixation implants. Possibility that the inner pouch may be compromised. The product is packaged in two pouches – a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if proper aseptic technique is not followed when transferring the inner package into the sterile field. Patient infection may o
Beckman Coulter Inc. Apr-01-2013 Access Immunoassay Systems – Access Immunoassay System; P/N 107405SProduct Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative; semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield; which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.
Roche Diagnostics Operations; Inc. Apr-01-2013 Roche Molecular Systems cobas¿ 4800 System – Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir; Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System; for in vitro diagnostics. Certain lots of Reagent reservoirs; may not have a separation in the lower part of the reservoir. As a consequence; pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Siemens Healthcare Diagnostics; Inc. Apr-02-2013 Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) – Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum; plasma; and urine. Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:Primeview 3i; Part No. 7341428; Current R610/R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE TH; Part No. 7339125;- Current R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE TH 2.1; Part No. 8147667; Current R640;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE TH 2.0; Part No. 8139839; Current R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE Impression TH; Part No. 7341410; Current R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE AG TH; Part No. 5863506; Current R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:Primeview 3i 2.1; Part No. 8147675; Current R640;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:Primeview 3i 2.0; Part No. 8139847; Current R630;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Siemens Medical Solutions USA; Inc Apr-02-2013 "COHERENCE RT Therapist – SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5; RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model:COHERENCE TH 2.2; Part No. 10568431; Current R640;Product Usage:The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer." Siemen’s issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Medtronic Neuromodulation Apr-02-2013 Prostiva – Medtronic Prostiva RF Therapy Generator.The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3. Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use; an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur; it could result in unintentionally starting or stopping the lesion process; depending on the current status of the equi
Cooper Surgical; Inc. Apr-03-2013 LEEP – LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure; a thin; low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure. LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit; which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
Polymedco; Inc Apr-04-2013 OC Light Manual iFOBT strips – Test Strips packaged in the OC-Light Manual iFOBT Kit; Catalog No. FOBSTR.For the rapid; qualitative detection of human hemoglobin in feces. The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
Arrow International Inc Apr-04-2013 Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Cathet – Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter.The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography; and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography. The product specifications sheet; part of the Instructions for Use (IFU); for the specified product numbers; reference Renografin-76 contrast medium (viscosity of 8.4 centipoise); which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime; when choosing an alternative contrast medium; health care providers are instructed to select a contrast
Polymedco; Inc Apr-04-2013 OC Light Manual iFOBT strips – Test Strips packaged in the OC-Light Manual iFOBT Kit; Catalog No. FOB50.For the rapid; qualitative detection of human hemoglobin in feces. The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.
LeMaitre Vascular; Inc. Apr-04-2013 LeMaitre Stent Guide – LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).Intended to be placed on the skin to assist during imaging procedures. Devices were not sealed correctly during the manufacturing process; and the sterility of these products have been compromised.
LeMaitre Vascular; Inc. Apr-04-2013 VascuTape Radiopaque Tape – Glow ‘N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).Intended to be placed on the skin to assist during imaging procedures. Devices were not sealed correctly during the manufacturing process; and the sterility of these products have been compromised.
Stryker Howmedica Osteonics Corp. Apr-05-2013 Stryker Triathlon – Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah; NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex FranceThe Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery. Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Synthes USA HQ; Inc. Apr-05-2013 Synthes Flexible Grip – Flexible Grip which is part of the Synthes Universal Nail System.Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures. Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System; due to the potential lack of the ability to thoroughly clean the instrument.
Covidien LP Apr-05-2013 Covidien Endo GIA – Covidien Endo GIA AutoSuture Universal Loading Unit; 30mm-2.0mm Product Code: 030450Applications in abdominal; gynecologic; pediatric anti thoracic surgery for resection; transection and creation of anastomosis. Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site; which may require medical intervention
Arrow International Inc Apr-06-2013 Arrow Internationa IABP – Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc;Product Number: IAB-05840-LWS.The IAB is utilized for intra-aortic balloon counter-pulsation therapy. Potential to have an internal leak at the fill port of the stainless steel tip; which may necessitate removal and replacement ofthe catheter.
Arrow International Inc Apr-06-2013 Arrow Internationa IABP – Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc;Product Number: IAB-05830-LWS.The IAB is utilized for intra-aortic balloon counter-pulsation therapy. Potential to have an internal leak at the fill port of the stainless steel tip; which may necessitate removal and replacement ofthe catheter.
Stelkast Co Apr-07-2013 Stelkast Cross-over Acetabular Shell and Liner Hip System – Stelkast Cross-over Acetabular Shell and Liner Hip System; Part Numbers SC3458-52; SC3474-52; SC3459-52; and SC3460-52.Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
Toshiba American Medical Systems Inc Apr-08-2013 TSX-30IC: AQUlLlON ONE; System; X-Ray; Tomography; Computed. – Toshiba TSX-30IC AQUlLlON ONE System; Computed Tomography X-Ray. This system supports Whole body scanning. Due to a problem with the control software of the x-ray high-voltage generator; if scanning is performed with a tube current less than 30mA; the control software may detect an error and perform error processing even though the x-ray output is normal.
AGFA Corp. Apr-08-2013 IMPAX CV 7.8 SU3 – OCR Service – IMPAX CV 7.8 SU3 – OCR Service.The IMPAX CV Reporting component facilitates the quick ; effective creation of digital structured reports for adult catheterization and echocardiography; pediatric echocardiography; congenital heart disease; nuclear cardiology and non-invasive vascular disease management. Software design error in IMPAX CV 7.8 SU3
Toshiba American Medical Systems Inc Apr-08-2013 T SX-IOI: AQUILION 32/64; System – T SX-IOI: AQUILION 32/64; System; X-Ray; Tomography; Computed.Designed to produce cross-sectional images of a human body. It was found that in vHP scan; the estimated DLP (total exposure dose of all scans in a singleexamination) value displayed in the eXam Plan window in scan planning and the DLP value displayed inthe summary after scanning are incorrect.
AGFA Corp. Apr-08-2013 IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting – IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.Facilitates digital reports for catheterization; echocardiography; and congenital heart disease. Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital’s electronic health record (EHR) system.
Elekta; Inc. Apr-09-2013 Precise Treatment Table – Precise Treatment Table.To be used as part of radiation therapy treatment process. The Column rotation can accidentally be moved to a different position which in the locked position.
J T Posey Company Apr-09-2013 Wrist restraint; wrist cuff – Posey Biothane Restraint Cuffs; Catalog Number 2900.The device is intended to limit a patient’s movement to the extent necessary for treatment or protection of the patient or others. The firm voluntarily recalled Biothane Restraint Cuffs; Catalog No. 2900; that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
Siemens Healthcare Diagnostics; Inc. Apr-09-2013 Dade(R) Actin(R) FSL Activated PTT Reagent – Dade(R) Actin(R) FSL Activated PTT Reagent.For use in the determination of the activated partial thromboplastin time (APTT). Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control; low and high.
Ormco/Sybronendo Apr-10-2013 "Bracket Buccal Tube – Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment" Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically; the BracketBuccal Tubes product package correctly identifies the product as gingival (0?) offset brackets; butactually contains distal (10?) offset brackets. Use of the affected product may cause unintended rotationof the molars. Although reversible; a delay in
GE Healthcare; LLC Apr-10-2013 – GE Healthcare Quasar Nuclear Medicine System; Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems; all configurations. Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
Kerr/Pentron; DBA Kerr Corporation and Pentron Clinical Apr-10-2013 Kerr Maxcem Elite – Kerr Maxcem Elite; self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0.Used for cementation of all indirect restorations. Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result; the restoration may not be seated properly.
Siemens Medical Solutions USA; Inc. Apr-10-2013 ACUSON SC2000 – Siemens brand ACUSON SC2000 Ultrasound System; Model 10433816; hardware that contains version 4 of the MPI board 10434200;The SC2000 ultrasound imaging system is intended for the following applications: Cardiac; Neo-natal and Fetal Cardiac; Pediatric; Transespohageal; Adult Cephalic; Peripheral Vessel; Abdominal; Abdominal Intraoperative; Intraoperative Neurological; Musculo-skeletal Conventional; and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. When using the V5M transducer; the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI Board. There is a potential to cause esophageal burns in patients.
GE Healthcare; LLC Apr-10-2013 VMX; VMX Plus – VMX; VMX Plus Mobile Radiographic Unit with the following models:45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173.Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care; emergencies; pediatrics; neonatology and orthopedics. GE Healthcare has become aware of an issue associated with the base casting for the articulated arm of your VMX andVMX Plus Mobile X-ray systems that may impact Operator or Patient safety.
Medtronic MiniMed Apr-10-2013 Medtronic MiniMed Paradigm Insulin Infusion Pumps – Medtronic MiniMed Paradigm Insulin Infusion PumpsModel Numbers: MMT-511; MMT-512; MMT-712; MMT-712E; MMT-515; MMT-715; MMT-522; MMT-522K; MMT-722; MMT-722K; MMT-523; MMT-523K; MMT-723; MMT-723K; MMT-554; and MMT-754.Product Usage:Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump’s drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump’s internal electronics. This moisture damage can prevent the pump’s buttons from working properly or can cause the pump to alarm.
Siemens Medical Solutions USA; Inc Apr-10-2013 ELEKTA MOSAIQ SW – ELEKTA MOSAIQ SW version below 2.41Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. A potential safety risk with the MOSAIQ OncologyInformation System that has been identified by the manufacturer IMPAC Medical Systems; Inc.
Thermo Fisher Scientific (Asheville) LLC Apr-10-2013 CO2 Incubators (General Purpose Incubator); – CO2 Incubators (General Purpose Incubator); model numbers 370; 371; 380; 381; 3307; 3308; 3310; 3311; 3540; 3541; 3542; 3543; 3584; 3585; 3598; and 3599.Product Usage:Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature; carbon dioxide; and humidity levels. Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Physio Control; Inc. Apr-10-2013 The LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators (AEDs) – The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part’s numbers: 3200731-xxx; 3202177-xxx; U3200731-xxx; and U3202177-006.Automated external defibrillators. LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Toshiba American Medical Systems Inc Apr-11-2013 MRI System – MRT-1504/A4 – Titan X MRI SystemMRT-30 I0A/5 – Titan 3T MRI SystemProduct Usage: MRI System. It was found that there is a problem with the LCD monitor used in the console. The LCD monitor maybecome blank during use. Specifically; the backlight of the LCD monitor may turn off while the systemis in use; causing the LCD monitor to become blank. However; the other parts of the system continue tooperate normally; and the risk of a serious health hazard is therefore very low. The LCD Moni
GE Healthcare; LLC Apr-11-2013 LOGIQ S8 and LOGIQ S7 Ultrasound System – GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1; R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso
US Endoscopy Group Inc Apr-11-2013 Torrent" irrigation tubing – Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids; such as sterile water; during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. The firm was notified by their customers that there was a water leakage from the white tubing connector.
Siemens Medical Solutions USA; Inc Apr-11-2013 Iconos R200 C20; Iconos R200 T20; Iconos R100; Iconos MD; Iconos RHD; Luminos RF Classic; Luminos Fu – Iconos R200 C20; Iconos R200 T20; Iconos R100; Iconos MD; Iconos RHD; Luminos RF Classic; Luminos Fusion or Luminos Select.Angiographic x-ray system. Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20; Iconos R200 T20; Iconos R100; Iconos MD; Iconos RHD; Luminos RF Classic; Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re
GE Healthcare; LLC Apr-11-2013 Discovery MR750w 3.0T System – GE Healthcare; Discovery MR750w 3.0T System. Part Number: 5352293.Product Usage: It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique images; spectroscopic images; parametric maps; and/or spectra;dynamic images of the structures and/or functions of the entire body; including; but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate;blood vessels; and musculoskeletal regions of the body. GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system.Image flip issue in frequency encoding direction (including S/I; A/P and R/L) can result in incorrect localization ofanatomy and pathological findings.
Integra LifeSciences Corp. Apr-12-2013 Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning – Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning;Software Versions 5.0.1 and 5.0.2.Intended for use in stereotactic and non-stereotactic (frameless stereotactic); collimated beam; computer planned; linear accelerator (Linac) based treatment. Depending on the system configuration; a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
Philips Medical Systems (Cleveland) Inc Apr-12-2013 Intellispace Portal (ISP) Philips Medical Systems (Cleveland); Inc.; – Intellispace Portal (ISP) Philips Medical Systems (Cleveland); Inc.;IntelliSpace Portal (ISP) is a multimodality (CT; NM; and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking; selection; processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality; ambient light conditions and image compression ratios are consistent with clinical application. Philips was notified of a problem using the IntelliSpace Portal with software version 4.0.2 with the URL PACS integration. Philips was informed that when loading a study to an analysis application while using URL PACS integration configuration; after another study was opened by a review application; the Analysis monitor is updated with the study of the current patient; but the Review monitor conti
Toshiba American Medical Systems Inc Apr-12-2013 Aplio 500/400/300 Diagnostic Ultrasound System – Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300).Device Listing Number: Dl53118.Diagnostic Ultrasound system. Toshiba Medical Systems has received reports of startup issues with the Toshiba TUS-500 andTUS-300 ultrasound systems. The startup issue is predominant when attempting to bring thesystem up from standby mode when the system is used remotely. It has been determined that thismay potentially cause damage to the system.
Siemens Medical Solutions USA; Inc Apr-12-2013 Siemens syngo WorkFlow SLR; Radiological Information System – Siemens syngo WorkFlow SLR; Radiological Information System; Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration; examination; reporting; statistics and system administration; as well as multiple interfaces for patient registration; order entry; and external billing modules. It is not intended to treat disease or administer any medicinal substances or drugs. There is no contact between device and patient. syngo(R) Workflow SLR can be used as a separate RIS; interfacing to a Hospital Information System (HIS) or Picture Archiving and Communication Systems (PACS Under certain conditions; when using the Search functionality; the potential exists for the wrong patient’s Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed; dismissed by the user; and then a different patient and signed exam is selected in single patient view. The Notes Viewer will
Ortho-Clinical Diagnostics Apr-13-2013 VITROS 5;1 FS Chemistry System and VITROS 5;1 FS Chemistry System Refurbished – VITROS 5;1 FS Chemistry System; Product Code 6801375 and VITROS 5;1 FS Chemistry System Refurbished; Product Code 6801890.Intended for use in the measurement of a variety of chemistry analytes. Ortho-Clinical Diagnostics; Inc. (OCD) determined that extension springs on some VITROS? Systems may beout of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility; it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force;
Ortho-Clinical Diagnostics Apr-13-2013 VITROS 4600 Chemistry System – VITROS 4600 Chemistry System (VITROS 5;1 FS System family member); Product Code 6802445.Intended for use in the measurement of a variety of chemistry analytes. Ortho-Clinical Diagnostics; Inc. (OCD) determined that extension springs on some VITROS? Systems may beout of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility; it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force;
Intuitive Surgical; Inc. Apr-13-2013 IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System – IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System; Model SI3000.Arm drapes protect equipment from contamination. Revised instructions for users of the da Vinci S; Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Intuitive Surgical; Inc. Apr-13-2013 IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System – IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System; Model IS2000.Arm drapes protect equipment from contamination. Revised instructions for users of the da Vinci S; Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Ortho-Clinical Diagnostics Apr-13-2013 VITROS 5600 Integrated System – VITROS 5600 Integrated System; Product Code 6802413.Intended for use in the measurement of a variety of chemistry analytes. Ortho-Clinical Diagnostics; Inc. (OCD) determined that extension springs on some VITROS? Systems may beout of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility; it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force
Edwards Lifesciences; LLC Apr-14-2013 Edwards Lifesciences Duraflo coated Fem-Flex II Femoral Arterial Cannula – Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage:The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired.The femoral arterial cannulae are wire-reinforced; thin-wall cannulae. Two unsealed pouches were found at an Edwards’ distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Siemens Healthcare Diagnostics; Inc Apr-15-2013 Siemens ADVIA Centaur Vitamin D Calibrator 6-pack – ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911.For use in the quantitative determination of Vit D. Negative bias in patient samples for Vitamin D
Siemens Healthcare Diagnostics; Inc Apr-15-2013 Siemens ADVIA Centaur Vitamin D Calibrator 2-pack – ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589.For use in the quantitative determination of Vit D. Negative bias in patient samples for Vitamin D
Siemens Healthcare Diagnostics; Inc Apr-15-2013 Siemens ADVIA Centaur Vitamin D Assay (500 tests) – ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021.For use in the quantitative determination of Vit D. Negative bias in patient samples for Vitamin D
Siemens Healthcare Diagnostics; Inc Apr-15-2013 Siemens ADVIA Centaur Vitamin D Assay (100 tests) – ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994.For use in the quantitative determination of Vit D. Negative bias in patient samples for Vitamin D
Roche Diagnostics Operations; Inc. Apr-15-2013 Accu-CheK Inform II Blood Glucose Monitor – ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner.Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar). Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
Roche Diagnostics Operations; Inc. Apr-15-2013 CoaguChek XS Pro meters – CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner.Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT"). Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
Advanced Sterilization Products Apr-15-2013 EVOTECH Endoscope Cleaner & Reprocessor System – EVOTECH Endoscope Cleaner & Reprocessor System; P/N 50004Designed to automatically clean and high-level disinfect flexible; submersible video or fiber-optic endoscopes. Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.
Abbott Laboratories; Inc Apr-15-2013 Clinical Chemistry Phenobarbital – Clinical Chemistry Phenobarbital; list number 1E08 Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the Phenobarbital assay is d 7% Total CV%; however; internal testing confirmed CVs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803UN12 is now expired; it exhibit
Carefusion Corporation Apr-15-2013 Alaris PC Unit 8015 – Alaris PC unit model 8015 with software version 9.12Product Usage:The Alaris PC unit is the central programming; monitoring and power supply component for the Alaris System The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
Biomet U.K.; Ltd. Apr-15-2013 Oxford Unicompartmental Toffee Hammer – REF 32-422760 Oxford Uni Knee System;Toffee Hammer; non-sterile; found in REF 32-422763 Oxford Mlcroplasty Knee SystemTibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set; used for impacting implants. Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle; which could lead to part of the head becoming detached from the handle.
Hospira Inc. Apr-15-2013 GemStar Infusion System – The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Hospira Inc. Apr-15-2013 GemStar Infusion System – The GemStar Pump is a small and lightweight; single channel infusion device designed for use in the home; in the hospital; or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor; rechargeable battery pack; docking station; or two disposable AA alkaline batteries. When powered by batteries; The GemStar Pump is ideal for ambulatory patients. During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Synvasive Technology Inc Apr-15-2013 Synvasive – Product is distributed by Zimmer (Warsaw; Indiana)/Synvasive Technology; Inc. (El Dorado Hills; CA) & manufactured under Synvasive Technology; Inc. El Dorado Hills; CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement. Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Accuray Incorporated Apr-16-2013 CyberKnife System Iris Variable Aperture Collimator – Accuray CyberKnife System Medical Physicist; Robotic Radiosurgery System; Medical charged-particle radiation therapy system; Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment. A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings; resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
Instrumentation Industries Inc Apr-16-2013 Manual Jet Ventilators; Manual Jet Ventilators w/Regulator and Guage; Small Bore Tubing Assembly – Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R RegulatorThe BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
GE Healthcare; LLC Apr-17-2013 GE Healthcare; AW Server. – GE Healthcare; AW Server.Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking; selection; processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server.After starting the Results Viewer with the selected series of a patient; the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occasional basis; when multiple users are simultaneously accessing the Results Viewe
Synvasive Technology Inc Apr-17-2013 Surgical Saw Blade Procedure Pack – The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTEDFor use with Stryker System 5; System 4; System 2000 and EDH. Product Usage: For use with Stryker System 5; System 4; System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction; and reciprocating blades for resection back and forth in a single plane. Biomet part # 506076; lot 928182 was received from Synvasive Technology containing the incorrect blade.
Alere San Diego; Inc. Apr-17-2013 Alere Cholestech LDX ALT AST Test Cassette – Alere Cholestech LDX ALT AST Test Cassette; Model #12-788.For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette; and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Philips Healthcare Inc. Apr-17-2013 Philips Healthcare Computed Tomography X-Ray System – Philips Healthcare Computed Tomography X-Ray System.These devices are whole-body computed tomography (CT) x-raysystems or sub-systems; each with a continuously rotating x-ray tubeand multi-row detectors enclosed by a gantry. X-ray transmissiondata acquired and taken at different angles can be reconstructed intocross-sectional images. Each device also includes signal analysisand display equipment; patient and equipment supports; components; and accessories. Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
Lifescan Inc Apr-17-2013 LifeScan OneTouch¿ Ultra Control Solution – LifeScan brand OneTouch¿ Ultra Control Solution; Part Numbers/Model Numbers: 01045808; 02141603.Testing of Blood Glucose Levels. When OneTouch? Ultra and OneTouch? Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
GE Healthcare; LLC Apr-17-2013 Muse v7 – GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd; Model Number 2026443-015: MUSE 7.0.2 app cd; Model number 2026443-017: MUSE 7.1 app cd; Model number 2026443-029:MUSE 7.1.1 A app cd; and Model Number 2026443-031: MUSE 7.1.1 app cd.Intended to store; access and manage cardiovascular information on adult and pediatrics patients. GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE; which could result in incorrect treatment.
Lifescan Inc Apr-17-2013 LifeScan OneTouch¿ Select Control Solution – LifeScan brand OneTouch¿ Select Control Solution; Part Number/Model #: 02168902.Testing of Blood Glucose Levels. When OneTouch? Ultra and OneTouch? Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
Sr Instruments Inc Apr-17-2013 Patient Scales – SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage:The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport. SR Instruments Inc. is implementing a field correction for the Joerns Healthcare Patient Lifts after they received two incident reports regarding two field failures of a tensile type load cell involving the FG3105 Patient Scale. The failures resulted in patient falls.
Edwards Lifesciences; LLC Apr-17-2013 Edwards Lifesciences Crimpers – Edwards Lifesciences Crimpers; Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
Edwards Lifesciences; LLC Apr-17-2013 Edwards Lifesciences Crimpers – Edwards Lifesciences Crimpers; Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
Smith & Nephew Inc Apr-17-2013 TRIGEN (TM) L-P SCREW; 4.5 MM X 37.5 MM – TRIGEN (TM) L-P SCREW; 4.5 MM X 37.5 MM; TI-6AL-4V; QTY: (1); STERILE R; REF 71645437; Smith & Nephew; Inc. Memphis; TN 38116 USAorthopedic surgery One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
Endogastric Solutions Inc Apr-17-2013 Endoscope Clip applier; Implantable Fastener and Accessories – EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***"Designed for the treatment of Gastroesophageal Reflux Disease (GERD); with erosive and non-erosive esophagitis EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Bacterin International; Inc. Apr-17-2013 OsteoSelect – OsteoSelect DBM PuttyProduct Usage:Orthopedic bone filler The firm’s retesting procedure was not validated.
DeGotzen Apr-17-2013 Generator; High-Voltage ; X- Ray Diagnostic – DeGotzen XRay unit XGenus Dental X-ray unit. It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Edwards Lifesciences; LLC Apr-18-2013 Pressure Monitoring sets – Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A; PXVP0566; PXVP2260; PXVP0826; PXVP0827; PXVP2284AT3; PXVP23X3AT3; T398807D; T100605B; T001762A; T391T00A; VP2.Blood sampling system used on patients requiring periodic withdrawal of blood samples. The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
Nipro Diagnostics; Inc. Apr-18-2013 Duane Reade TRUEtrack monitor kit – Duane Reade TRUEtrack monitor kit; UPC# 6 39194 01679 7 Part # A4006-81The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes. Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Advanced Sterilization Products Apr-18-2013 EVOTECH – EVOTECH Endoscope Cleaner and Reprocessor System; P/N 50004.Designed to automatically clean and high-level disinfect flexible; submersible video or fiber-optic endoscopes. Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.
GE Healthcare; LLC Apr-18-2013 GE Healthcare; Innova 2100IQ; Innova 3100IQ; Innova 4100IQ – GE Healthcare; Innova 2100IQ; Innova 3100IQ; Innova 4100IQ; Cardiovascular and Interventional Imaging System. As part of GE Innova IQ table introduction; a label was designed to be affixed on the front Cover of theGantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor; nurse; operator; anesthetist; etc&) stands in the region between the C-arm gantry pivot and the head section of the table; there is a risk of co
Horiba Instruments; Inc dba Horiba Medical Apr-18-2013 ABX PENTRA 400 I.S.E. Module – HORIBA ABX PENTRA 400 I.S.E. Module; Model Numbers: P400ISE110EN02 and P400ISE110US02; All Serial Numbers; Software Versions 5.0.7 and Below.Used to measure absorbance and ion electrodes. HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are noLinearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. Allother assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above thevalidated linearity range for each assay.
Heritage Labs International LLC Apr-18-2013 A2376 Extra Supplies Kit – Heritage Labs Path Study Extra Supplies Kit; Product # A 2376; kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles–all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD; Franklin Lakes; NJ. The kit is used by health care providers when treating patients. The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Transonic Systems Inc Apr-18-2013 AV Loop Kit – HCS3011 AV Loop Kit For use with Transonic CO status System Only; -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters. Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Vital Images; Inc. Apr-18-2013 Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 – Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation; Vitrea fX; VitreaAdvanced and Vitrea Enterprise Suite; through version 6.4.Vitrea¿ CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries; heart; and surrounding tissue. Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface.
Siemens Healthcare Diagnostics; Inc. Apr-18-2013 Dimension Vista(R) System Vista Drug 4 Calibrator – Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
Acist Medical Systems Apr-18-2013 ACIST – ACIST Medical Systems Inc.The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots; ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection; and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed w
Elana; Inc. Apr-18-2013 Elana Catheter Sizer 2.0 – Elana Catheter Sizer 2.0***The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique. Distribution of an unapproved device into interstate commerce.
Maquet Cardiovascular; LLC Apr-18-2013 CARDIOHELP-i – MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0)Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours). It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown; followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device; where measured values; settings and alarms are displayed and adjusted/confirmed; with the exception of bl
Nova Biomedical Corporation Apr-19-2013 Nova StatStrip Glucose Test Strips – Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)Catalog # 42214 Glucose test strips reports no result message when tested
Ortho-Clinical Diagnostics Apr-19-2013 VITROS Chemistry Products PHBR Slides – VITROS Chemistry Products PHBR (Phenobarbital) Slides; REF 822 1384.For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision; outliers; or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD’s investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
Nova Biomedical Corporation Apr-19-2013 Nova StatStrip Glucose Test Strips – Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)Catalog # 51493 (UK Only) Glucose test strips reports no result message when tested
Accuray Incorporated Apr-20-2013 RoboCouch Patient Positioning System – RoboCouch Patient Positioning SystemProduct Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
Teleflex Medical Apr-22-2013 Belly Bag Urine Collection Bag with Hip Belt. – Belly Bag Urine Collection Bag with Hip Belt.The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter. Sterile packaging may be compromised.
Stellate Systems Apr-22-2013 Harmonie software versions 5.1 uo to 6.2e : – Harmonie software versions 5.1 uo to 6.2e :Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD; HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP)Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector; Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector; Spindle Detector; Heart Rate Processor; Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector; Cerebral Function Monitor Trend; Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers ; The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.
Spinal Solutions; LLC Apr-22-2013 APLIF Implants and Instruments – APLIF Implants and Instruments; Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm – 10degree184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm – 10degree184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm – 10degree184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm – 10degree184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm – 10degree184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm – 00degree184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm – 00degree184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm – 00degree184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm – 00degree184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm – 00degree184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm – 10degree184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm – 10degree184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm – 10degree184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm – 10degree184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm – 10degree184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm – 00degree184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm – 00degree184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm – 00degree184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm – 00degree185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm – 10degree185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm – 10degree185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm – 10degree185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm – 10degree185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm – 10degree185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm – 00degree185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm – 00degree185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm – 00degree185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm – 00degree185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm – 00degree185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm – 10degree185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm – 10degree185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm – 10degree185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm – 10degree185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm – 10degree185508-00 Anterior Psoas Lumbar 18 x 55 x 08mm – 00degree185510-00 Anterior Psoas Lumbar 18 x 55 x 10mm – 00degree185512-00 Anterior Psoas Lumbar 18 x 55 x 12mm – 00degree185514-00 Anterior Psoas Lumbar 18 x 55 x 14mm – 00degree185516-00 Anterior Psoas Lumbar 18 x 55 x 16mm – 00degreeThe Eminent Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine; from L2 to S1; in skeletally mature patients who have had six months of non-operative treatment. Spinal Solutions is recalling the APLIF system because it is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage; movement; or inadequate sterilization.
Orthopedic Alliance LLC Apr-22-2013 Orthopedic Alliance Spine System (alias "Blue & Gold") – Orthopedic Alliance Spine System (alias "Blue & Gold")Part Numbers:BGC3010 Screw CapBGR0040 Straight Rod 5.5 x 40mmBGR0050 Straight Rod 5.5 x 50mmBGR0060 Straight Rod 5.5 x 60mmBGR0070 Straight Rod 5.5 x 70mmBGR0080 Straight Rod 5.5 x 80mmBGR0090 Straight Rod 5.5 x 90mmBGR0100 Straight Rod 5.5 x 100mmBGR0110 Straight Rod 5.5 x 110mmBGR0120 Straight Rod 5.5 x 120mmBGR0130 Straight Rod 5.5 x 130mmBGR0140 Straight Rod 5.5 x 140mmBGR0150 Straight Rod 5.5 x 150mmBGR0200 Straight Rod 5.5 x 200mmBGR0300 Straight Rod 5.5 x 300mmBGR0400 Straight Rod 5.5 x 400mmBGR0500 Straight Rod 5.5 x 500mmBGS5535 5.5 x 35mm Polyaxial ScrewBGS5540 5.5 x 40mm Polyaxial ScrewBGS5545 5.5 x 45mm Polyaxial ScrewBGS6035 6.0 x 35mm Polyaxial ScrewBGS6040 6.0 x 40mm Polyaxial ScrewBGS6045 6.0 x 45mm Polyaxial ScrewBGS6050 6.0 x 50mm Polyaxial ScrewBGS6535 6.5 x 35mm Polyaxial ScrewBGS6540 6.5 x 40mm Polyaxial ScrewBGS6545 6.5 x 45mm Polyaxial ScrewBGS6550 6.5 x 50mm Polyaxial ScrewBGS7035 7.0 x 35mm Polyaxial ScrewBGS7040 7.0 x 40mm Polyaxial ScrewBGS7045 7.0 x 45mm Polyaxial ScrewBGS7050 7.0 x 50mm Polyaxial ScrewBGS7055 7.0 x 55mm Polyaxial ScrewBGS7535 7.5 x 35mm Polyaxial ScrewBGS7540 7.5 x 40mm Polyaxial ScrewBGS7545 7.5 x 45mm Polyaxial ScrewA pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage; loosening; or inadequate sterilization.
Philips And Neusoft Medical Systems Co.; Ltd. Apr-23-2013 NeuViz 16 Multi-Slice CT Scanner System – NeuViz 16 Multi-Slice CT Scanner System; Part number (PN): 989605858501; Model: NeuViz 16. This is a computed X-ray; Tomography system.The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Philips And Neusoft Medical Systems Co.; Ltd. Apr-23-2013 NeuViz Dual series CT Scanner System – NeuViz Dual series CT Scanner System; Part number (PN): 989605651321. This is a computed X-ray; Tomography system.NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles. User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Varian Medical Systems; Inc. Oncology Systems Apr-23-2013 Varian – Varian brand RPM Respiratory Gating System; RPM Gating v1.7.5 with 3D Option; Model Number: HS2Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion. Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block; this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
GE Healthcare; LLC Apr-23-2013 Xeleris 2 Processing & Review Workstation – GE Healthcare; Xeleris 2 Processing & Review Workstation.The display; processing; archiving; and communication of data acquired by Emission Tomography cameras used in diagnostic radiology; including procedures for planar imaging; whole body imaging; tomographic (SPECT) imaging; positron imaging by coincidence; attenuation correction; and anatomical image registration GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data); that may impact patient safety.On imported CT scans; Myocardial Perfusion Imaging (MPI) studies may create artifacts in attenuation corrected images. This may lead to a potential for misdiagnosis.
Beckman Coulter Inc. Apr-24-2013 AU5800 Clinical Chemistry Analyzer – AU5800 Clinical Chemistry AnalyzerThe Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples; in combination with appropriate reagents; calibrators; quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric; turbidimetric; latex agglutination; homogeneous enzyme immunoassay; and in selective electrode. Beckman Coulter; Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
GE Healthcare; LLC Apr-24-2013 Ventri Discovery NM 530c – Ventri Discovery NM 530c; Ventri with Premium Table Discovery NM 530c; models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan; the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
DePuy Mitek; Inc.; a Johnson & Johnson Co. Apr-25-2013 ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 – ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC); Catalog Number: 223113.For use in general soft tissue approximation; and/or ligation; including orthopedic procedures. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures; it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study; a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
DePuy Mitek; Inc.; a Johnson & Johnson Co. Apr-25-2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 – ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC); Catalog Number: 223111.For use in general soft tissue approximation; and/or ligation; including orthopedic procedures. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures; it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study; a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
DePuy Mitek; Inc.; a Johnson & Johnson Co. Apr-25-2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles – ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles; Product Code: 223116.For use in general soft tissue approximation; and/or ligation; including orthopedic procedures. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures; it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study; a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
DePuy Mitek; Inc.; a Johnson & Johnson Co. Apr-25-2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles – ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles; Catalog Number: 223114.For use in general soft tissue approximation; and/or ligation; including orthopedic procedures. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures; it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study; a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
DePuy Mitek; Inc.; a Johnson & Johnson Co. Apr-25-2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles – ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles; Product Code: 223115.For use in general soft tissue approximation; and/or ligation; including orthopedic procedures. The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures; it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study; a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
Alere San Diego; Inc. Apr-25-2013 Alere Cholestech LDX¿ hsCRP Test Cassette; – The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette; Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. The Alere Cholestech LDX? hsCRPcassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert;which may cause differences in quantitative results for hsCRP compared to a reference method orrepeat testing on the same patient sample.
B. Braun Medical; Inc. Apr-26-2013 Diacap(R) Ultra Dialysis Fluid Filter – Diacap(R) Ultra Dialysis Fluid Filter; Catalog Number 7107367.Intended to filter bacteria and endotoxins from dialysis fluid. There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time; which results in the reduction of the membrane permeability (ultrafiltration coefficient).
Vital Images; Inc. Apr-26-2013 Vitrea¿ – Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea; Vitrea fX; VitreaAdvanced and Vitrea Enterprise Suite.Noninvasive post-processing application designed to evaluate areas of brain perfusion. Vital Images; Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays; misdiagnosis or mistreatment.
Siemens Medical Solutions USA; Inc Apr-26-2013 Siemens ARTISTE; ONCOR and PRIMUS systems. – Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE; ONCOR and PRIMUS systems.ARTISTE; ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. Software update to fix multiple safety related issues.
Advanced Sterilization Products Apr-26-2013 STERRAD Cyclesure – STERRAD CYCLESURE 24 Biological Indicator (BI)The STERRAD CYCLESURE 24 Biological Indicator (BI); is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
GE Healthcare; LLC Apr-29-2013 GE; VCT for Discovery VCT; Discovery RX VCT; and Discovery PET/CT 690; Lightspeed VCT; Discovery CT7 – GE; VCT for Discovery VCT; Discovery RX VCT; and Discovery PET/CT 690; Lightspeed VCT; Discovery CT750HD.Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission. Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking; spilling oil within the gantry and outside the system. This issue affects GE Healthcare VCT for Discovery VCT; Discovery RX VCT; and Discovery PET/CT 690; Lightspe
Discus Dental LLC Apr-29-2013 SL3 SOFT-TISSUE Laser – SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental; LLC; 8550 Higuera Street; Culver City CA 90232.The SL3 is a soft-tissue diode laser intended to be used for dental procedures The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
Masimo Corporation Apr-29-2013 Pulse Oximeter – Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous; noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that; when moved; can power off without the operator pressing the power button.
Covidien LLC Apr-29-2013 Covidien Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode – Medi-Trace Cadence Adult Radiotransparent Defibrillation ElectrodeProduct ID: 22550R.Intended for use in cardioversion; pacing; ECG monitoring; and defibrillation procedures. Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire; which could render the device incapable of delivering the appropriate energy or shock to the patient
Covidien LLC Apr-29-2013 Covidien Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode – Medi-Trace Cadence Pediatric Radiotransparent Defibrillation ElectrodeProduct ID: 22550P.Intended for use in cardioversion; pacing; ECG monitoring; and defibrillation procedures. Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire; which could render the device incapable of delivering the appropriate energy or shock to the patient
Philips Healthcare Inc. Apr-29-2013 HeartStart MRx Defibrillator – HeartStart MRx Monitor/Defribillator; Product Codes: M3536A; M3536J; M3536M; M3536MC; M3536M2; M3536M4; M3536M5; M3536M6.The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.