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January 2011 - vol. 20:01

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.

A-DEC INC., Newberg, Oregon. Dental Chair: Decade Plus 1221. Class II. Firm initiated recall ongoing. Firm notified users by letter March 23, 2009. Volume in Commerce: 2,723 units. Reason: The design of the chair backrest create a possible pinch-point between the chair backrest and the underside of the arm rests. FDA recall #Z-0541-2011. FDA Enforcement Report, 12/22/10.

CUTERA INC., Brisbane, California. Heating Lamp: Titan XL Handpiece Infrared Therapeutic Heating Lamp. All products manufactured before October 1, 2009 with gold plated end blocks. Class II. Firm initiated recall ongoing Firm notified users by letter May 8, 2010. Volume in Commerce: 1,344 units. Reason: Risk of burns -- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.. FDA recall #Z-0329-2011. FDA Enforcement Report, 12/29/10.

DIXTAL MEDICAL, INC., Wallingford, Connecticut. Pulse Oximetry: 1) Handheld Pulse Oximetry Model 513; 2) Handheld Pulse Oximetry Model 512. Class II. Firm initiated recall ongoing Firm notified users by email and letter dated September 27, 2010. Volume in Commerce: 39 units. Reason: Unit may overestimate SpO2 levels in a high humidity environment. FDA recalls #Z-0550/0551-2011. FDA Enforcement Report, 12/29/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan; GE Hangwei Medical Systems Co., Ltd. Beijing, China; GE Healthcare, LLC, Waukesha, Wisconsin. CT Scanner: 1) LightSpeed VCT Scanner System; 2) BrightSpeed Excel/Edge/Elite Select/Elite CT Scanner System. Class II. Firm initiated recall ongoing. Firm notified users by letters dated September 2, 2010 and September 24, 2010. Volume in Commerce: 1,014 units. Reason: GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems. FDA recalls #Z-0368/0369-2011. FDA Enforcement Report, 12/22/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan. MR Systems: 1) Signa OpenSpeed, 0.7T; 2) Signa Ovation, 0.35T. Class II. Firm initiated recall ongoing. Firm notified users by letter dated August 20, 2010. Volume in Commerce: 378 units. Reason: If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury. FDA recalls #Z-0425/0426-2011. FDA Enforcement Report, 12/22/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Vascular/Cardiac X-ray: 1) Innova 4100/4100IQ GE Innova 4100/4100IQ; 2) Innova 2000. Class II. Firm initiated recall ongoing. Firm notified users by letters dated July 9, 2009. Volume in Commerce: 408 units. Reason: GE has become aware of a video splitter failure that may impact patient safety. The failure could occur without warning and thereby prevent x-ray image display. Should this occur, the system cannot be recovered without service intervention. To date no injury has been reported related to this condition. FDA recalls #Z-0392/0393-2011. FDA Enforcement Report, 12/22/10.

GE HEALTHCARE, LLC, Waukesha, Wisconsin: Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Vascular/Cardiac X-ray: 1) Innova 2121-IQ/3131; 2) Innova 2100IQ; 3) Innova 3100/3100IQ GE Innova 3100/3100 IQ; 4) Innova 4100/4100IQ GE Innova 4100/4100 IQ. Class II. Firm initiated recall ongoing. Firm notified users by letters dated August 4, 2009. Volume in Commerce: 615 units. Reason: GE has become aware of a potential issue that may impact patient safety. GE Fluoro UPS is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment will be returned to the main hospital power. UPS fluoro battery degradation could occur due to long storage conditions impacting the life expectancy of sealed cell batteries. The fluoro UPS could be potentially unavailable if it is not periodically maintained as prescribed in the service documentation and Operator Manual delivered with the Innova system. FDA recalls #Z-0407/0410-2011. FDA Enforcement Report, 12/22/10.

MEDTRONIC NAVIGATION, INC., Littleton, Massachusetts. Navigation O-Arm Imaging System: Door Assembly. Class II. Firm initiated recall ongoing Firm notified users by letter dated October 15, 2010. Volume in Commerce: 244 units. Reason: Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-Arm Imaging System. Breakage of door cable during opening and closing may occur and cause physical harm or delay of therapy. FDA recall #Z-0447-2011. FDA Enforcement Report, 12/22/10.

PHILIPS HEALTHCARE, INC., Andover, Massachusetts. Defibrillator/Monitor: HeartStart MRx Models: M3535A/M3536A/M3536J/M3536MC. Class II. Firm initiated recall ongoing. All units shipped from February 11, 2004 through June 25, 2010. Firm notified users by letter July 20, 2010. Volume in Commerce: 41,119 units. Reason: Updated Instructions for Use-HeartStart MRx monitor/defibrillator. The update provides more detailed information on: “Default ECG Lead Behavior” Synchronized Cardioversion using External Paddles. FDA recall #Z-0322-2011. FDA Enforcement Report, 12/29/10.

PHILIPS MEDICAL SYSTEMS, Seattle, Washington. Defibrillator - AED: 1) HeartStart FR2+ AED # M3860 Philips; 2) HeartStart FR2+ AED # M3861 Philips; 3) Heartstart FR2+ AED with ECG, #3840 Laerdal brand; 4) Heartstart FR2+ AED #3841 Laerdal; Class II. Firm initiated recall ongoing. Firm notified users by letter May 28, 2010. Volume in Commerce: 72,428 units (20,419 units subject to this recall). Reason: Failure of the voltage detector, U8 may cause the AED battery to drain more rapidly than normal or make the AED unusable. FDA recalls #Z-0470/0473-2011. FDA Enforcement Report, 12/22/10.

PHILIPS MEDICAL SYSTEMS, San Jose, California: Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, Ohio.. Gamma Cameras: SKYLight Gamma Camera Gearbox brake – component of the SKYLight Gamma Camera 3/8” SPECT and 5/8” SPECT. Class II. Firm initiated recall ongoing. Firm notified users by letter dated November 3, 2010. Volume in Commerce: 24 units. Reason: Detector arm assembly may slide to hardware limit, potentially causing impact. FDA recall #Z-0398-2011. FDA Enforcement Report, 12/22/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. MR Coils: 1.5T coils and accessories – Philips Achieva and Intera 1.5T MR Systems. Synergy Flex-M/Shoulder Coil 1.5T Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter dated May 1, 2009 and October 14, 2009. Volume in Commerce: 389 units. Reason: Combined use of the Synergy Flex-M/Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient. FDA recall #Z-0469-2011. FDA Enforcement Report, 12/22/10.

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. PHILIPS, Bothell, Washington Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. R/F System: Easy Diagnost Eleva Conventional R/F System. Class II. Firm initiated recall ongoing. Firm notified users by letter dated January 27, 2009. Volume in Commerce: 314 units. Reason: Patient and image data can be exchanged when a patient is selected in the patient list and the examination table is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment. FDA recall #Z-0479-2011. FDA Enforcement Report, 12/22/10.

SIEMENS MEDICAL SOLUTIONS USA, INC., Malvern, Pennsylvania: Manufacturer: Siemens Medical Solutions, Inc., D-91056 Erlanger, Germany. Mobile X-Ray: Mobilett XP and Mobilett XP Hybrid. Model numbers 181836 and 1818454. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 4, 2010. Volume in Commerce: 177 units. Reason: Units not equipped with protective plastic cover over electronics. FDA recall #Z-0171-2011. FDA Enforcement Report, 12/29/10.

STRYKER MEDICAL DIV. of STRYKER CORP., Portage, Michigan. Ambulance Cot: M1 Ambulance Cot model 6100. Class II. Firm initiated recall ongoing. Firm notified users by letters dated May 15, 2010. Volume in Commerce: 7,314 units: Arizona, California, Colorado, Florida, Louisiana, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, Tennessee and internationally. Reason: The firm has received 42 complaints regarding the head end lock rod, head end slide tube, brushing, and upper cross tube failures. FDA recall #Z-0328-2011. FDA Enforcement Report, 12/29/10.