BEUDAMED
    FDA Recall Terminated

    OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

    Recall: Z-1705-2008 · Initiated April 15, 2008

    Recall

    Recall Number
    Z-1705-2008
    Event Number
    47774
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 15, 2008
    Posted
    September 1, 2008
    Terminated
    December 21, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

    Reason

    Use of existing four-pedal footswitch on a different machine may cause various operational errors.

    Action

    Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.

    Distribution

    Nationwide, including one VA facility in FL. No military or foreign distribution.

    Quantity

    78 units