BEUDAMED
    FDA Recall Terminated

    OEC 9900 Elite. MDL Numbers: D148942, D155043

    Recall: Z-1060-2017 · Initiated December 27, 2016

    Recall

    Recall Number
    Z-1060-2017
    Event Number
    76074
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    December 27, 2016
    Posted
    January 20, 2017
    Terminated
    July 12, 2018
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC 9900 Elite. MDL Numbers: D148942, D155043

    Reason

    GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.

    Action

    The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.

    Distribution

    Worldwide including govt/VA/military and foreign consignees.

    Quantity

    26,256 total