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May 2011 - vol. 20:07

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: DEFIBTECH, L.L.C., Guilford, Connecticut. Defibrillator- AED: 1) Lifeline DDU-100; b) ReviveR DDU-100. Volume in Commerce: 65,885 units. Firm notified users in February 2011 and FDA notified users by Medwatch Press Release and recall in March 2011 and posted in May. Reason: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction. Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech at http://www.defibtech.com/fa111 to see if their devices are listed. FDA/MEDWATCH: March 14, 2001/May 10/2011.

Class I: SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, California: Manufacturer: Impac Medical Systems Inc., Sunnyvale, California. Electronic Patient Records Management System: LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Firm initiated recall ongoing. Firm notified users by correction notification of March 23, 2011. Reason: Siemens sent an Urgent Medical Device Correction letter on March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the Safety Advisory Notice in their LANTIS owner manual and contact their Siemens Service Engineer or Application Specialist or Lantis4.healthcare@siemens.com. Volume in Commerce: 47 units. Reason: There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital information system (HIS) when the HL7 (ADT) interfact is used. FDA recall #Z-2151-2011. FDA Enforcement Report, 05/11/11.

ARJO, INC. dba ArjoHuntleigh, Addison, Illinois: Manufacturer: B.H.M. Medical, Inc., Magog Quebec, Canada. Ceiling Lift System: Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift; a patient transfer lift. Class II. Firm initiated recall ongoing. Firm notified users by letter dated March 4, 2011.Volume in Commerce: 1,246 units.Reason: The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable. FDA recall #Z-1983-2011. FDA Enforcement Report, 05/04/11.

ALLIED HEALTHCARE PRODUCTS, INC., Saint Louis, Missouri: Manufacturer: Allied Healthcare Products, Inc., Stuyvesant Falls, New York. CarbO2Lime Absorbent Granules -- Carbon Dioxide Absorbent Granules for Canister Refill (Soda Lime). Class II. Firm initiated recall is complete. Firm notified users by letters dated February 25, 2011.Volume in Commerce: 949 pails, 335/12 canister cases, and 706/12 refill bag cases.Reason: The granules do not absorb as long as expected in the anesthesia machines. FDA recall #Z-2152-2011. FDA Enforcement Report, 05/11/11.

BECKMAN COULTER INC., Brea, California: Manufacturer: Horiba ABX SAS, Montpellier, France. Hematology Analyzer: Coulter AC-T 5diff Autoloader. Class II. Firm initiated recall ongoing. Firm notified users by letter dated February 23, 2011.Volume in Commerce: 1,211 units.Reason: Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT, and MVP without instrument generated messages for the first run of a capped patient sample. With repeated analysis the results are correct, but acceptance of false readings could: 1) delay treatment; 2) cause permanent damage if improper treatment resulted; 3) affect clinical assessment of patient. FDA recall #Z-1979-2011. FDA Enforcement Report, 05/04/11.

BECKMAN COULTER INC., Brea, California: Manufacturer: Beckman Coulter, Inc., Miami, Florida. Clinical Systems: UniCel DxC 600. Class II. Firm initiated recall ongoing. Firm notified users by letter dated November 16, 2010. Volume in Commerce: 1,535 units. Reason: The hose clamps in the DxC (w/serial numbers< 3412) are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly. FDA recall #Z-1972-2011. FDA Enforcement Report, 05/04/11.

BECKMAN COULTER INC., Brea, California: Manufacturer: Beckman Coulter, Inc., Miami, Florida. Hematology Analyzer: Floor Cabinet: UniCel DxH 800 Floor Cabinet. Class II. Firm initiated recall ongoing. Firm notified users by letter dated October 20, 2010. Volume in Commerce: 422 units with 175 in US. .Reason: Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers with a potential for exposure to blood borne pathogens such as HIV, HBV, and HCV. FDA recall #Z-1980-2011. FDA Enforcement Report, 05/04/11.

ELLEX MEDICAL PTY LTD, Adelaide, Australia. Laser: 1) ELLEX Super Q LQP3106 ophthalmic laser; 2) ELLEX Ultra Q LQP3106-U ophthalmic laser; 3) Alcon 3000LE ophthalmic laser; 4) plus two models old outside the USA. (Tango and Solo). Class II. Firm initiated recall ongoing. Firm notified users by Service Bulletin dated February 25, 2011.Volume in Commerce: 2,335 units.Reason: Unintended laser emission while the user was moving the joystick for targeting. FDA recalls #Z-1840/1844-2011. FDA Enforcement Report, 05/04/11.

HOSPIRA INC., Lake Forest, Illinois: Manufacturers: Hospira Holdings de, Costa Rica Ltd., Costa Rico; Hospira Inc., Morgan Hill, California. Infusion Pump: GemStar SP Infusion Suite Database, version 1.0; an Rx PC software application. A stand-alone PC application for administration of medications specific to the GemStar Infuser. Class II. Firm initiated recall is ongoing; firm notified users by letters dated March 23, 2011. Volume in Commerce: 139 units. Reason: The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application. FDA recall #Z-1999-2011. FDA Enforcement Report, 05/04/11.

OEC MEDICAL SYSTEMS, INC., Salt Lake City, Utah. Sensor Cables: GE Healthcare Surgery. 1) Transmitter Sensor Cables used with InstraTrak Navigation Systems., Models IT3000, IT2500, IT2500+, IT3500, & IT3500+; 2) Receiver Sensor Cables used with InstraTrak, Models IT3000, IT2500+, IT3500, IT3500+. Firm initiated recall ongoing. Firm notified users by letter dated March 1, 2011. Volume in Commerce: 708 systems. Reason: Sensor cables may suffer material degradation when exposed to certain sterilization procedures. FDA recalls #Z-1941/1942-2011. FDA Enforcement Report, 05/18/11.

PHILIPS HEALTHCARE INC., Andover, Massachusetts. Monitor System: Philips IntelliVue Clinical Information Portfolio Software. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 16, 2011. Volume in Commerce: 387 units. Reason: Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended. FDA recall #Z-2175-2011. FDA Enforcement Report, 05/18/11.

PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC., Cleveland Ohio: Manufacturer: Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China. CT: MX 16- slice. Class II. Firm initiated recall ongoing. Firm notified users by letter dated March 10, 2011. Volume in Commerce: 168 units. Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, and Texas. Reason: The CT scanners are subject to recall/field correction due to an inaccurate dimension measurements with the potential for misdiagnoses. FDA recall #Z-2059-2011. FDA Enforcement Report, 05/04/11.

SIEMENS MEDICAL SOLUTIONS USA, INC., Mountain View, California. Ultrasound System: a) Acuson S2000, Model 10434730; ABVS (Automated Breast Volume Scanner): 1) Boom Welding; 2) Arm Welding. Class II. Firm initiated recall complete. Firm notified users by telephone and email on March 28, 2011. Volume in Commerce: 10 units. Reason: The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off the unit. FDA recall #Z-2150-2011. FDA Enforcement Report, 05/11/11.

STERIS CORPORATION HOPKINS FACILITY, Mentor, Ohio. Liquid Chemical Sterilant Processing System: The System 1E System. (Manufactured from 5/5/2010 through 3/8/2011) Class II. FDA initiated recall ongoing. Firm notified users by letter dated March 14, 2011. Volume in Commerce: 106 units. Reason: The printout, display, and Operator Manual for the system are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemical* (not **sterilized), when alerting the user to incomplete processing. FDA recall #Z-1960-2011. FDA Enforcement Report, 05/04/11.

TOSHIBA AMERICAN MEDICAL SYSTEMS. Tustin, California: Manufacturer: Toshiba Electron Tubes & Devices Co., Ltd, Otawa-Shi, Tochigi, Japan. Diagnostic Ultrasound: SSH-880CV Apilio Artida. Class II. Firm notified users by letter on April 20, 2010. Volume in Commerce: 14 units. Reason: There is a possibility of the system shutting down owing to the power supply unit causing the protection function to activate thus turning off the system prematurely. FDA recall #Z-2179-2011. FDA Enforcement Report, 05/18/11.