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April Supplement 2011 - vol. 20:06

FDA Recalls and/or Manufacturer Product Advisories and Field Corrections

Product distribution is nationwide unless otherwise specified. Contact the Home Office in Dallas for additional information. We cannot always include the serial and lot numbers affected by each recall, as both are often extensive. We also include recalls designated as COMPLETE. The “COMPLETE” designation does not guarantee that all users have been contacted – but signifies that FDA had determined that the manufacturer or supplier has completed due diligence to notify users; in addition, all recall information is significant to the repair history of the device and may: a) help clarify a past intermittent problem whose cause could not be fully explained at time of occurrence or b) provide valuable information for consideration during pre-purchase evaluations.

ROCHE INSULIN DELIVERY SYSTEMS, INC., Fishers, Indiana: Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. ACCU-CHEK Infusion Sets: Subcutaneous Infusion sets for micro dosage insulin pumps – 13 types of sets, Class I. Firm initiated recall ongoing. Firm notified users by letter dated February 21, 2011. Volume in Commerce: 1,454,918 infusion sets. Reason: There is a potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to underdelivery and elevation of blood glucose levels. FDA recalls #Z-1480/1492-2011. FDA Enforcement Report, 03/23/11.

HILL-ROM, INC., Batesville, Indiana. Patient Beds: a) TotalCare beds P1900 with P500 Microclimate Management Surface; b) VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface; c)VersaCare P500 Microclimate Management Surface Upgrade kits. Class II. Firm initiated recall ongoing. Firm notified users by letters dated February 21, 2011.Volume in Commerce: 2,475 units.Reason: Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate. Patients may experience some reduced efficacy with managing skin temperature and moisture due to the reduced operation of the MCM blower. Please note that the mattress will continue to provide pressure redistribution to the patient, as the pump supplying air to the mattress bladders will continue to operate. FDA recalls #Z-1563/1565-2011. FDA Enforcement Report, 03/16/11.

HILL-ROM, INC., Batesville, Indiana: Manufacturer: Liko AB, Lulea, Sweden. Patient Lifts: Liko Sabine and Capella sit-to-stand lifts – 7 models; from 1997 to present. Class II. Firm initiated recall ongoing. Firm notified users by letters dated January 27, 2011 and a follow-up dated February 9, 2011. Volume in Commerce: 1,009 units.Reason: The firm has received reports of injuries related to the lifts. Of six injury reports, two were injuries in patients during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit. FDA recalls #Z-1691/1697-2011. FDA Enforcement Report, 04/06/11.

HOSPIRA INC., Lake Forest, Illinois: Manufacturers: Hospira Holdings de, Costa Rica Ltd., Costa Rico; Hospira Inc., Morgan Hill, California. Infusion Pumps: a) Plum A+ Single Channel; b) Plum A+3 Triple Channel; c) Plum A+ Hyperbaric Single Channel. Class II. FDA initiated recall is ongoing; firm notified users by letter February 14, 2011. Volume in Commerce: 167,595 pumps. Reason: Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. FDA recalls #Z-1644/1646-2011. FDA Enforcement Report, 03/23/11.

HOSPIRA INC., Lake Forest, Illinois: Manufacturers: Hospira Holdings de, Costa Rica Ltd., Costa Rico; Hospira Inc., Morgan Hill, California. Infusion Pumps: a) Plum XL Single Channel; b) Plum XL Micro/Macro Single Channel; c) Plum XL Micro/Macro with DataPort Single Channel; d) Plum XL3 Triple Channel; e) Plum XL Micro/Macro Triple Chanel; f) Plum XL3 Micro/Macro with DataPort Triple Channel. Class II. FDA initiated recall is ongoing; firm notified users by letter February 14, 2011. Volume in Commerce: 205,689 pumps. Reason: Hospira has received customer reports of the Plum XL, XLM, and XLD Infusion Pumps with no audible alarm at the low audio setting. FDA recalls #Z-1597/1602-2011. FDA Enforcement Report, 03/16/11.

HOSPIRA INC., Morgan Hill, California. Power Cord: used on Symbiq One- and Two Channel Infuser. Class II. Firm initiated recall is ongoing; firm notified users by letter on November 1, 2010. Volume in Commerce: 32,376 cords. Reason: Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, and burnt smell have been reported on Symbiq AC power cords. FDA recall #Z-1596-2011. FDA Enforcement Report, 03/16/11.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Defibrillator/Monitor: HeartStart MRx with software versions F.01.00 or F.01.01 and hardware options: StCO2, IP, and Temp. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 7, 2011. Volume in Commerce: 2,382 units. Reason: EtCO2 and Ventilation Rate values may be labeled incorrectly. FDA recall #Z-1609-2011. FDA Enforcement Report, 04/06/11.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. General Purpose Diagnostic Radiology: BuckyDiagnost with Optimus Generator.. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 6, 2011. Volume in Commerce: 2,002 units. Reason: Affected systems were determined not to prevent run-on of a selected technique factor if the technique selector and the exposure control were activated simultaneously. FDA recall #Z-0905-2011. FDA Enforcement Report, 03/30/11.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington: Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Mobile C-arm Systems: a) BV Libra; b) BV Endura, Rel. 2; c) BV Pulsera, Rel. 2.3. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 5, 2011. Volume in Commerce: 227 units (3 BV Libra; 10 BV Endura; 214 BV Pulsera). Reason: The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems. FDA recalls #Z-1603/1605-2011. FDA Enforcement Report, 04/06/11.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington: Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Radiology - diagnostic, fluoroscopic, angiographic, and interventional applications: a) Allura Xper Systems with Velara Generator; b) Allura Integris Systems with OMCP Generator; c) MultiDiagnost Eleva; d) OmniDiagnost Eleva. Class II. Firm initiated recall ongoing. Firm notified users by letters on October 15, 2010. Volume in Commerce: 2,658 units. Reason: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a system breakdown. FDA recalls #Z-1654/1657-2011. FDA Enforcement Report, 03/23/11.

PHYSIO CONTROL, INC., Redmond, Washington. Defibrillator – Lifepak 20 and 20e. Class II. Firm initiated recall ongoing. FDA initiated recall; firm notified users by letter beginning May 27, 2010. Volume in Commerce: 53,480 units. Reason: A component failure on the AC power supply assembly results in “NO AC POWER” operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted. FDA recall #Z-1722-2011. FDA Enforcement Report, 03/30/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound System: a) Acuson and Sonoline Antares and Antares PE. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 1, 2010. Volume in Commerce: 3,539 units. Reason: Image captured from the device may be erroneous. FDA recall #Z-1853-2011. FDA Enforcement Report, 04/06/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound Transducer: VSM TEE when used with the Acuson S2000 Ultrasound System. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 28, 2009. Volume in Commerce: 115 units. Reason: If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees C. FDA recall #Z-1392-2011. FDA Enforcement Report, 03/30/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Malvern, Pennsylvania: Manufacturer: Siemens Medical Solutions Inc., D-91056 Erlanger, Germany. X-Ray System: AXIOM SIRESKOP SD, SX, LUMINOS (flat panel/digital imager). Class II. Firm initiated recall ongoing. Firm notified users by letter on January 14, 2011. Volume in Commerce: 1,323 units. Reason: Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPT Grip become stuck under the housing. FDA recall #Z-1421-2011. FDA Enforcement Report, 03/30/11.

TOSHIBA AMERICAN MEDICAL SYSTEMS. Tustin, California: Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Diagnostic Ultrasound: SSH-880CV Apilio Artida. Class II. Firm initiated recall ongoing. Firm notified users by letter on September 28, 2010. Volume in Commerce: 40 units. Reason: Toshiba America Medical Systems is initiating a filed correction on the ultrasound system due to software issues. FDA recall #Z-1498-2011. FDA Enforcement Report, 03/09/11.

ZEVEX INTERNATIONAL, INC., Salt Lake City Utah. Infusion Administration Sets Curlin Infusion Tubing – 18 model numbers. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 24, 2011. Volume in Commerce: 1,432,870 devices nationwide: Arkansas, California, Florida, Iowa, Kansas, Mississippi, Nebraska, New York, Ohio, Oklahoma, Tennessee, Texas, and Utah. Reason: Defect in tubing may trigger false Air-In-Line warning. FDA recalls #Z-1439/1456-2011. FDA Enforcement Report, 03/09/11.