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December 2010 vol. 19:17

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.

Class I – BAXTER HEALTHCARE, CORP., Round Lake Illinois: Baxter Healthcare, Corp., Singapore. Infusion Pumps:1) Colleague Single Channel; 2) Colleague Triple Channel. Class I. Firm initiated recall ongoing. Firm first notified users by letters dated August 4, 2010. Volume in Commerce: 302,872 units. Reason:The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of it’s Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use.FDA recalls #Z-0001/0002-2011.FDA Enforcement Report, 11/17/10.

Class I – CAREFUSION CORP., San Diego, California. Infusion Pumps: Alaris PCUnit Model 8015 (formerly Medley PC Unit); Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC100005572 manufactured and serviced between May 7, 2009 and September 8, 2009. Class I. Firm initiated recall is ongoing.Firm notified users by letter beginning August 24, 1010. Volume in Commerce: 17,081 units. Reason: Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy.A delay of therapy may result in serious injury and/or death.FDA recall #Z0006-2011. FDA Enforcement Report, 11/17/10.

Class I – HOSPIRIA INC., Morgan Hill, California.Infuser:1) Symbiq One-Channel; 2) Symbiq Two-Channel. Class I. Firm initiated recall ongoing. Firm first notified users by letters February 22, 2010 and October 4, 2010. Volume in Commerce: 23,478 units. Reason:Motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy. FDA recalls #Z-0127/0128-2011.FDA Enforcement Report, 12/08/10.

CAREFUSION CORP., San Diego, California. Infusion Pump: PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Class II. Firm initiated recall ongoing beginning August 24, 2010. Volume in Commerce:94,146 units.Reason:PC may under certain conditions display an incorrect total dose when programmed to deliver a bolus dose. The Pump or Syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose. Potential Risk: If the display of an incorrect dose is detected, it has a potential to confuse clinicians and may lead to a delay in therapy or over-or-under infusion of a therapy, which may result in serious injury and/or death.FDA recall #Z-0492-2011.FDA Enforcement Report, 12/08/10.

DRAEGER MEDICAL SYSTEMS, INC., Telford, Pennsylvania: Manufacturer: Draeger Medical B.V., Best Netherlands.Ventilator: Oxylog 3000, emergency and transport ventilator. Class II.Firm initiated recall ongoing. Firm notified users by letter dated August 2010.Volume in Commerce:78 devices.Reason:Patient received insufficient ventilation. The Oxylog 3000 instructions are inadequate relating to dead space volume.FDA recall #Z-0018-2011.FDA Enforcement Report, 11/17/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: Datex-Ohmeda, Inc., Madison, Wisconsin. Anesthesia Machines: 1) Aisys Anesthesia Systems; 2) Avance Anesthesia Systems; 3) Amingo Anesthesia Systems. Class II.Firm initiated recall ongoing. Firm notified users by letters dated August 30, 2010.Volume in Commerce:7,711 units. Reason:Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventilation, resulting in hypoventilation and hypoxia.FDA recalls #Z-0008/0010-2011.FDA Enforcement Report, 11/17/10.

HILL-ROM, INC., Batesville, Indiana. Bariatric Bed: 1) Excel Care, P 610A; 2) Excel Care ES P 610B.Class II.Firm initiated recall ongoing. Firm notified users by letters dated March 5, 2010.Volume in Commerce:1,406 beds. Reason:The firm received complaints regarding the side rails not operating correctly or becoming inoperable. The side rails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers.FDA recalls #Z-0332/0333-2011.FDA Enforcement Report, 12/08/10.

PHILIPS MEDICAL SYSTEMS, Seattle, Washington.Defibrillator - AED:1) HeartStart FR2+ AED with ECG Display # M3860 Philips; 2) HeartStart FR2+ AED with Text Display (no ECG) # M3861 Philips); 3) Heartstart FR2+ AED with ECG, #3840 Laerdal brand; 4) Heartstart FR2+ AED with Text Display (no ECG) #3841 Laerdal; 5) Heartstart FR2+ AED with ECG, #9898903148601; 6) Heartstart FR2+ AED with Test Display, #989803148611.Class II. Firm initiated recall ongoing. Firm notified users by letter October 5, 2010. Volume in Commerce: 27,270 units (7393 nationally and 19,877 internationally). Reason:A flash memory component in the HeartStart FR 2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.FDA recalls #Z-0483/0488-2011.FDA Enforcement Report, 12/15/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.C-Arms:1) BV Pulsera R2.2 Mobile X-Ray System; 2) BV Endura R2.2 Mobile X-Ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter October 4, 2008. Volume in Commerce: 1,409 units (113 BV Endura and 1296 BV Pulsera). Reason:Reliability of the Stand-Trolley cable may result in loss of images on the monitor during examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor.FDA recalls #Z-0140/0141-2011.FDA Enforcement Report, 11/24/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.X-Ray Systems:1) Allura Xper FD10 Monoplane; 2) Allura Xper FD10/10 Biplane. Class II. Firm initiated recall ongoing. Firm notified users by letter September 15, 2010. Volume in Commerce: 57 units. Reason:Potential for table and stand not to move due to software error.FDA recalls #Z-0124/0125-2011.FDA Enforcement Report, 12/08/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.X-Ray Systems:1) Allura Xper FD10 Systems with Velara Generator X-Ray; 2) Allura Integris Systems with OMCP Generator; 3) MultiDiagnost-Eleva Systems; 4) OmniDiagnost-Eleva Imaging Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 14, 2010. California Iowa, Indianan, Kansas, Louisiana, Michigan, Minnesota, Mississippi, New York, Ohio and Texas. Volume in Commerce: 2,658 units. Reason:A wired in the connector of the Generator Grid Switch Supervisor might short circuit between the 12-volt power and ground. If a short circuit occurs it may cause the system to break down. If the system fails during a critical interventional case it may cause risk to patients. (No Fluoro is available).FDA recalls #Z-0324/0327-2011.FDA Enforcement Report, 12/08/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany.X-Ray Systems-Accessories:1) BABIX holder used with the BuckyDiagnost X-Ray system to hold the baby either in a secured or immobilized standing position during the examination; 2) BABIX holder used with the DigitalDiagnost X-Ray system to hold the baby either in a secured or immobilized standing position during the examination;. Class II. Firm initiated recall ongoing. California, Georgia, & Tennessee. Firm notified users by letter September 9, 2010. Volume in Commerce: 1) 4 units; 2) 1 unit. Reason:Potential of broken strands in the main steel cable supporting g the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.FDA recalls #Z-0021/0022-2011.FDA Enforcement Report, 11/17/10.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, California: Manufacturer: Siemens Ag Medical Solutions, Kemnath, Germany.Patient Table:550 TxT.Class II.Firm initiated recall ongoing. Firm notified users by letters dated March 31, 2010.Volume in Commerce: 326 units. Reason:An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the table. Both issues present the potential for injury to the patient or the operator. FDA recall #Z-0166-2011.FDA Enforcement Report, 12/01/10.

VERATHON, INC., Bothell, Washington.BladderScan:1) BVI 9600 Bladder Volume Instrument, w/Aorta Scan Mode; 2) AortaScan AMI 9700; 3) BladderScan BVM 9500.Class II.Firm initiated recall ongoing. Firm notified users by letters dated August 12, 2010.Volume in Commerce: a) 351 units; b) 73 units; c) 260 units. Reason:The BladderScan BVI 9600 with AortaScan may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function. FDA recalls #Z-0003/0005-2011.FDA Enforcement Report, 11/17/10.

WINCO, INC., Ocala, Florida.Care Cliner Chair:a multi position recliner with a steel frame. Class II. Firm initiated recall ongoing. Firm notified users by letters dated October 1, 2010.Volume in Commerce: 18,522 casters. Reason:Malfunctioning axles which become loose from the caster assembly. FDA recall #Z-0147-2011.FDA Enforcement Report, 12/08/10.