BEUDAMED
    FDA Recall Terminated

    MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

    Recall: Z-0704-06 · Initiated March 28, 2006

    Recall

    Recall Number
    Z-0704-06
    Event Number
    34990
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2006
    Posted
    September 30, 2006
    Terminated
    July 25, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

    Reason

    Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.

    Action

    Consignees were notified by letter prior to 04/28/2006.

    Distribution

    Nationwide.

    Quantity

    534 units (Domestic), 125 (Intl)