The Commitment Makes The Difference

“Providing quality and cost-effective biomedical equipment services since 1978.”

Around the MBI Circuit

Modern Biomedical

October 2011 - vol. 20:13

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.

BAYER HEALTHCARE, LLC., Mishawaka, IN. Contour TS Blood Glucose Test Strips. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 12th, 2011. Volume in Commerce: 3,617,287 vials / 54,555,460 test strips. Reason: All 10 or 25 count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour USB blood glucose meters are being recalled, a packaging issue which, under certain conditions, can cause some test strips packaged in small count vials to operate outside of the US FDA cleared performance specifications and produce a low basis reading during blood glucose testing. FDA recall #Z-3268-2011. FDA Enforcement Report, 10/12/11.

BOSTON SCIENTIFIC CRM CORP., Saint Paul, MN. Manufacturers: Benchmark Electronics Inc., Winona, MN; Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Latitude Patient Management System Communicator. Class II. Firm initiated recall ongoing. Firm notified users by letter in August 2011. Volume in Commerce: 470 units. Reason: A limited number of Model 6476 and 6482 Latitude Communicators are unable to authenticate and thus cannot connect to the Latitude System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message. FDA recall #Z-3283-2011. FDA Enforcement Report, 10/5/11.

CARDIAC SCIENCE CORP., Bothell, WA. Manufacturer: Cardiac Science Corp., Deerfield, WI. Powerheart Automated External Defibrillator (AED). Class II. Firm notified users by letter on August 1st, 2011. Volume in Commerce: 195,739 units. Reason: Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self-test errors cause the device to enter into a service required state. CSC remind owners / operators of the Powerheart AED devices to verify the “Rescue Readiness” of their equipment and follow maintenance procedures as specified in operation and maintenance guides provided with every AED. FDA recall #Z-3265-2011. FDA Enforcement Report, 10/12/11.

CINCINNATI SUB ZERO PRODUCTS, INC., Cincinnati, OH. Warm Air Model 135 Hyperthermia System. Class II. Firm initiated recall ongoing. Firm notified users by letter on July 27th, 2011. Volume in Commerce: 6,561 units. Reason: Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 device Operation and Technical Manuals in order to comply with FDA device labeling regulations. FDA recall #Z-3119-2011. FDA Enforcement Report, 9/28/11.

GE HEALTHCARE, LLC., Waukesha, WI. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Datex-Ohmeda Tru Sat Pulse Oximeter and Accessories, Model 3500 (GE Healthcare). Class II. Firm initiated recall ongoing. Firm notified users by letter on March 30th, 2011. Volume in Commerce: 31,846 units. Reason: The plastic enclosure on the external power supply of the Tru Sat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. FDA recall #Z-3206-2011. FDA Enforcement Report, 9/28/11.

GE HEALTHCARE, LLC., Waukesha, WI. Manufacturer: GE Medial Systems, SCS, Buc Cedex, France. Advantage Windows (Workstation) with FUNCTOOL OPTION. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 18th, 2011. Volume in Commerce: 697 units. Reason: GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor / FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety. FDA recall #Z-3282-2011. FDA Enforcement Report, 10/5/11.

INVACARE CORP., Elyria, OH. Manufacturer: Hebei HealthPlus Medical Device Co., LTD, Handan City, China. Dual Blue-Release Adult Walkers. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 7th, 2011. Volume in Commerce: 12,764 walkers. Reason: The firm is conducting a recall / correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. FDA recall #Z-3280-2011. FDA Enforcement Report, 10/5/11.

TERUMO CARDIOVASCULAR SYSTEMS CORP., Ann Harbor, MI. Terumo Sarns Level Sensor II Pads. Class II. Firm initiated recall ongoing. Firm notified users by letter on August 10th, 2011. Volume in Commerce: 1,531,440 devices. Reason: Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. FDA recall #Z-3176-2011. FDA Enforcement Report, 9/28/11.

TOSHIBA AMERICA MEDICAL SYSTEMS INC., Tustin, CA. Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Aquilion X Ray System. Class II. Firm initiated recall ongoing. Firm notified users by letter on June 22nd, 2011. Volume in Commerce: 155 units. Reason: Toshiba America Medical Systems is initiating a field correction on their TSX-301B: AQUILION Premium System X Ray, Tomography, Computed, TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed, TSX-201A: AQUILION LB; System, X-Ray, Tomography, Computed, and TSX-101A: AQUILION 16 System X-Ray, Tomography, Computed due to several software issues that cause the scanners to function incorrectly. FDA recall #Z-3195/3198-2011. FDA Enforcement Report, 9/28/11.