BEUDAMED
    FDA Recall Terminated

    Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden

    Recall: Z-1203-2007 · Initiated July 10, 2007

    Recall

    Recall Number
    Z-1203-2007
    Event Number
    38428
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 10, 2007
    Posted
    September 7, 2007
    Terminated
    December 7, 2007
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden

    Reason

    Overcharging of batteries and the release of acid fumes

    Action

    Safety Alert letters were sent out by FedEx tracking. A Service Express letter will be sent out emphasizing that only qualified batteries must be used in KION equipment and will list all qualified battery types. A Field Action - update of existing operating manuals will include warning on battery charging on KION. This action is currently scheduled to start 9/1/07 and be completed in US by 10/1/07. After FDA consultation the recalling firm issued a 9/5/2007 URGENT DEVICE CORRECTION Letter stating that KION will visit consignees and replace batteries older than three years, verify that the batteries are ones of the approved type, and verify battery condition.

    Distribution

    Nationwide: 2 units at the National Institute of Health in Bethesda, MD and 7 units at Oconee Regional Medical Center, Milledgeville, GA

    Quantity

    9 units in US