BEUDAMED
    FDA Recall Terminated

    OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.

    Recall: Z-0556-2007 · Initiated February 9, 2007

    Recall

    Recall Number
    Z-0556-2007
    Event Number
    37322
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 9, 2007
    Posted
    March 22, 2007
    Terminated
    June 26, 2007
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.

    Reason

    During routine service, a cover may have been installed without the required proper lead shielding.

    Action

    Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.

    Distribution

    Nationwide to AL, AZ, IA, OH, TX, VA, and WV.

    Quantity

    11 units of all models