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February 2010: vol. 19:02

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 – EDWARDS LIFESCIENCES, LLC, Irvine, California: Manufacturer: NIKKISO Medical Systems GmbH, Hannover, Germany. Fluid Monitor: Aquarius System monitoring the fluid going into and coming out of the patient. Class I. Firm initiated recall ongoing. Firm notified users by letter dated March 19, 2009. Volume of Product in Commerce: 2,272 units. Reason: Reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. FDA recall #Z-0653-2010.. FDA Enforcement Report, 02/03/10.

Class I – HETTICH INSTRUMENTS MANAGEMENT I., Beverly, Massachusetts: Manufacturer: Andreas Hettich GmbH & Co. Kg, Tuttlingern, Germany. Centrifuge:. 1) Mikro 12-24 Centrifuge with 2050 Rotor, 2) Haematokrit 24 with 2050 Rotor, 3) Mikro 20 with 2076 Rotor, 4) Haematokrit 20 with 2050 Rotor. Class I. Firm initiated recall ongoing. Firm notified users by email on November 21, 2009 and letter dated November 23, 2009. Volume of Product in Commerce: 46 devices. Reason: Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge. FDA recalls #Z-0612/0615-2010. FDA Enforcement Report, 02/03/10.

B. BRAUN MEDICAL, INC., Allentown, Pennsylvania: Manufacturer: B. Braun Medical, Inc., Santa Domingo, Dominican Republic. Outlook Pump IV Sets: 49 models. Class II. Firm initiated recall is ongoing. Firm notified users by letters dated November 30, 2009 and December 1, 2009. Volume in Commerce: 5,435,249 units. Reason: System error 9 alarms indicating a potential pressure loss in the pump cassette delivery chamber. This alarm is generated during the pumps' initiation sequence and will not allow the set to be utilized. This requires a new set to be obtained, thus creating a potential for delay in therapy. FDA recalls #Z-0670/0718-2010. FDA Enforcement Report, 02/03/10.

GE HEALTHCARE, Wauwatosa, Wisconsin. Bone Densitometer: 1) IDXA, GE Lunar DEXA, 2) Prodigy 1-8 series, GE Lunar DEXA, 3) DPX-NT series, GE Lunar DEXA, 4) DPX-MD series, GE Lunar DEXA, 5) DPX-Bravo/Duo, GE Lunar DEXA. Class II. Firm initiated recall is ongoing. Firm notified users by letter on November 2,2009, Volume in Commerce: 1,764 units. Reason: Failure to properly pre-indicate the technique factors to be used during a patient scan. FDA recalls #Z-0600/0604-2010. FDA Enforcement Report, 02/03/10.

GE HEALTHCARE, Salt Lake City Utah. C-Arm: 1) GE/OEC 9900 Elite ESP, 2) GE/OEC 9900 Elite GSP. Class II. Firm initiated recall is ongoing. Firm notified users by letter beginning October 5, 2009. Volume in Commerce: 1,395 units. Reason: Software defect – may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate. FDA recalls #Z-0004/0005-2010. FDA Enforcement Report, 02/03/10.

GE MEDICAL SYSTEMS, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems China Co., Ltd., Wuxi, China. ECG: MAC 800 Resting ECG Analysis System. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated December 10, 2009. Volume in Commerce: 567 units. Reason: Problems with laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. FDA recall #Z-0645-2010. FDA Enforcement Report, 02/03/10.

GE MEDICAL SYSTEMS, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems SCS, Buc Cedez, France. Imaging Tables: 1) Omega IV and Omega V on GE Advantx-E, 2) Omega IV and Omega V tables on Innova 2100IQ, 3) Omega IV and Omega V tables on Innova 3100/3100IQ, 4) Omega IV and Omega V tables on Innova 4100/4100IQ, 5) Omega IV and Omega V tables on Innova 2000, 6) Omega IV and Omega V tables on Innova 2121-1Q/3131-1Q. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated December 1, 2009. Volume in Commerce: 3,635 units. Reason: An unintended table rotation while the table is locked could lead to a patient fall if the unintended motion occurs during patient transfer. FDA recalls #Z-0616/0621-2010. FDA Enforcement Report, 01/20/10.

GE MEDICAL SYSTEMS, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria. Ultrasound – Voluson E6, E8, and E8 Expert. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated October 22, 2009. Volume in Commerce: 715 units. Reason: Incorrect operating procedure may impact patient safety. FDA recall #Z-0541-2010. FDA Enforcement Report, 01/13/10.

GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHNOLOGY, Milwaukee, Wisconsin. Telemetry – GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software). Class II. Firm initiated recall is ongoing. Firm notified users by letter dated September 25, 2009. Volume in Commerce: 8,305 units. Reason: Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. FDA recall #Z-0631-2010. FDA Enforcement Report, 01/20/10.

INVACARE CORPORATION, Elyria, Ohio. Wheelchair. Invacare Storm TDX SR Power Wheelchair with Stability Lock. Class II. Firm initiated recall is ongoing. Firm notified users by letters on September 15, 2009. Volume in Commerce: 36 units: Arizona, California, Colorado, Connecticut, DC, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Mexico, New York, Ohio, South Carolina, Texas and Canada . Reason: If the stability lock does not engage properly the chair may veer to one side, rock forward, drive in an unintended circular motion, or fall forward or to one side with a risk of injury to the user. FDA recall #Z-0579-2010. FDA Enforcement Report, 01/13/10.

KCI USA, INC., San Antonio, Texas: Manufacturer: Electri-Cord Manufacturing Co., Westfield, Pennsylvania. AC Power Cords: used with Low Air Loss Therapy: 1) Kinair IV, 2) Triadyne, 3) Therapulse ATP/II, 4) Kinair Medsurg, 5) Kinair Medsurg Pulse, 6) Tricall, 7) First Step, 8) Plexipulse, 9) Activac, 10) InfoVAC Class II. Firm initiated recall is ongoing. Firm notified users by letter dated November 4, 2009. Volume in Commerce: 791 units. Reason: Power cords may crack and fall inside plug with potential for fire hazard. FDA recall #Z-0662/0667-2010. FDA Enforcement Report, 02/03/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Fetal Monitors: 1) Avalon Fetal Monitor FM 20, 2) Avalon Fetal Monitor FM 30, 3) Avalon Fetal Monitor FM 40, 4) Avalon Fetal Monitor FM 50. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 23, 2009. Volume in Commerce: 18,940 units. Reason: Potential for inaccurate ultra-sound derived fetal heart rate readings leading to inaccurate clinical decisions. FDA recalls #Z-0549/0552-2010. FDA Enforcement Report, 01/13/10.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Patient Monitors: 1) SureSigns Patient Monitors (VM3, VM4, VM6, VM8), 2) SureSigns Vital Signs Monitors (VS3) – Vital Signs Viewer Central Viewer Station View up to 12 VM Monitors, 3) SureSigns Vital Signs Viewer (VSV); Spot Check Vital Signs Monitor. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 2009. Volume in Commerce: 49,648 units. Reason: Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker. FDA recalls #Z-0372/0374-2010. FDA Enforcement Report, 01/27/10.

SMITHS MEDICAL ASD, INC., St. Paul, Minnesota. Infusion Pumps: 1) Medfusion Model 3500 syringe infusion pump, 2) Medfusion model 3010a syringe infusion pump. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 16, 2009. Volume in Commerce: 5,436 units. Reason: Increased trend of Motor Not Running (MNR) and Motor Rate Error (MRE) alarm messages. If a MNR/MRE alarm message event occurs during start up or during infusion, the pump will provide a visual and audible alarms and the pump will not operate. FDA recalls #Z-0650/0651-2010. FDA Enforcement Report, 01/20/10.

TELEFLEX MEDICAL, Durham, North Carolina: Manufacturer: Teleflex Medical, Tamaulipas, Mexico. Hudson RCI One-Way Valve. Class II. Firm initiated recall is ongoing. Firm notified users by letters beginning December 4, 2009. Volume in Commerce: 2,450 units. Reason: Incorrect packaging. The valve may be placed in the circuit in the wrong orientation for gas flow. FDA recall #Z-0652-2010. FDA Enforcement Report, 01/20/10.

TELEFLEX MEDICAL, Durham, North Carolina: Manufacturer: Sensidyne, Inc., Clearwater, Florida. Oxygen Sensor. Class II. Firm initiated recall is ongoing. Firm notified users by letters on or about November 25, 2009. Volume in Commerce: 51 units: Florida, Kentucky, Michigan, Ohio, Pennsylvania, South Dakota, Tennessee, Australia and Canada. Reason: Sensor causes the oxygen to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment. FDA recall #Z-0585-2010. FDA Enforcement Report, 01/13/10.

ZAP LASERS LLC, Pleasant Hill, California. Dental Laser: SoftLase Pro Dental Lasers. Class II. Firm initiated recall is ongoing. Firm notified users by letter dated December 30, 2009. Volume in Commerce: 1,375 units. Reason: Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedules. FDA recall #Z-0587-2010. FDA Enforcement Report, 02/03/10.