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April 2012 - vol. 21:04

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 RECALL: NELLCOR PURITAN BENNETT INC., (dba Covidien LP), Boulder, CO. Manufacturer: Covidien LLC, Norwood, MA. BIS Bilateral Sensors. Firm initiated recall ongoing. Firm notified users by letter on November 8th, 2011. Volume in Commerce: 8,510 units (851 boxes of 10). Reason: During manufacture, circuit traces were reversed which causes inaccurate display of information. FDA recall #Z-0802-2012. FDA Enforcement Report, 4/25/12.

CLASS I RECALL: SALTER LABS, Arvin, CtelephoneA, Salter Labs Bubble Humidifier. Firm initiated recall ongoing. Firm notified users by telephone on October 21st, 2011. Volume in Commerce: 6,060 units. Reason: A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak. FDA recall #Z-0803-2012. FDA Enforcement Report, 4/18/12.

CLASS I RECALL: SMITHS MEDICAL ASD, INC. Gary, IN. Bivona Tracheostomy Tubes. Class I. Firm initiated recall ongoing. Firm notified users by letter on November 28th, 2011. Volume in Commerce: 147,523 units. Reason: Smiths Medical discovered customer reports regarding difficulty disconnecting accessories from the Bivona Uncuffed, Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach the accessory, this may result in decannulation of the tube which could result in serious injury or death; especially if no replacement tracheostomy tube is immediately available. FDA recall #Z-0656/0671-2012. FDA Enforcement Report, 4/25/12.

GE HEALTHCARE, LLC, Waukesha, WI. Innova X Ray Imaging Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on May 4th, 2011. Volume in Commerce: 19 units Reason: When the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation. FDA recall #Z-1124-2012. FDA Enforcement Report, 4/18/12.

LEICA MICROSYSTEMS INC., Buffalo Grove, IL. Manufacturer: Leica Microsystems (Schweiz) Ag. Heerbrugg, Switzerland. Touch Panel / Control Unit Carrier of the Swingarm, component of Surgical Microscope. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 27th, 2012. Volume in Commerce: 33 units. Reason: The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch panel / control unit of the surgical microscope to disconnect, which potentially could result in them falling. FDA recall #Z-1269-2012. FDA Enforcement Report, 4/11/12.

MAQUET INC., Wayne, NJ. Manufacturer: Maquet Critical Care AB, Solna Sweden. Servo-i and Servo-s ventilator system. Class II. Firm initiated recall ongoing. Firm notified users by letter on December 22nd, 2011. Volume in Commerce: Servo-i 647 units and Servo-s 50 units. Reason: The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC / DC convertor can result in electric shock during servicing. FDA recall #Z-1362/1363-2012. FDA Enforcement Report. 4/11/12.

MOOG MEDICAL DEVICES GROUP, Salt Lake City, UT. Curlin Ambulatory Infusion Pump System. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 20th, 2012. Volume in Commerce: 876,460. Reason: Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. FDA recall #Z-1401/149-2012. FDA Enforcement Report, 4/25/12.

PHILIPS HEALTHCARE INC., Andover, MA. MD Eleva System. Class II. Firm initiated recall ongoing. Firm notified users by letter on November 19th, 2011. Volume in Commerce: 92 units. Reason: The air karma rate is not displayed correctly on the user interface. FDA recall #Z-1212-2012. FDA Enforcement Report, 4/11/12.

PHILIPS HEALTHCARE INC., Andover, MA. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. MultiDiagnost Eleva IITV. Class II. Firm initiated recall ongoing. Firm notified users by letter on October 3rd, 2011. Volume in Commerce: 10 units. Reason: Incorrect Skin Dose Calculation. AKR (Air Karma Rate) displayed and stored in patient records is too low. FDA recall #Z-0985-2012. FDA Enforcement Report, 4/18/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance Workspace Portal. Class II. Firm initiated recall ongoing. Firm notified users by letter on February 8th, 2012. Volume in Commerce: 822 units. Reason: Incorrect Standardized Uptake Value (“SUV”) values are displayed in two instances: 1. After loading PET data (with Slope value different from 1) into the Quick Review application from a remote device and 2. During the loading the above mentioned type of PET data in to the CT viewer application from a remote device. FDA recall #Z-1219-2012. FDA Enforcement Report, 4/4/12.

PHILIPS MEDICAL SYSTEMS, (Cleveland) Inc., Cleveland, OH. Brilliance 64 and Ingenuity CT X Ray Systems. Class II. Firm initiated recall ongoing. Firm notified users by letter on March 14th, 2012. Volume in Commerce: 440 units. Reason: Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan. FDA recall #Z-1361-2012. FDA Enforcement Report, 4/11/12.

QRS DIAGNOSTIC, Maple Grove, MN. Universal ECG 12 Channel ECG (IEC). Class II. Firm initiated recall ongoing. Firm notified users by letter on February 9th, 2012. Volume in Commerce: 13 devices. Reason: The chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretation by the Office Medic Software. FDA recall #Z-1315-2012. FDA Enforcement Report, 4/4/12.

SIEMENS MEDICAL SOLUTIONS USA, INC., Concord, CA. Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. MOSAIQ System. Class II. Firm initiated recall ongoing. Firm notified users by letter on April 14th, 2012. Volume in Commerce: 44 devices. Reason: Images used in treatment planning may belong to another patient causing a risk of treatment to wrong area. Software update is needed to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5, for RT Therapist version 2.1A. FDA recall #Z-1270-2012. FDA Enforcement Report, 4/4/12.