BEUDAMED
    FDA Recall Terminated

    GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.

    Recall: Z-0989-2007 · Initiated July 6, 2007

    Recall

    Recall Number
    Z-0989-2007
    Event Number
    38339
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 6, 2007
    Posted
    July 12, 2007
    Terminated
    February 1, 2013
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.

    Reason

    The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

    Action

    Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.

    Distribution

    Worldwide, including USA, France, Singapore, Sweden, and Switzerland.

    Quantity

    22 units