BEUDAMED
    FDA Recall Terminated

    GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

    Recall: Z-0341-2009 · Initiated August 29, 2008

    Recall

    Recall Number
    Z-0341-2009
    Event Number
    50083
    Firm
    OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 29, 2008
    Posted
    January 5, 2009
    Terminated
    April 24, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

    Reason

    Under certain conditions, x-ray system may experience operational impairment.

    Action

    Consignees were notified by letter on 08/29/2008. Interim solutions were provided for proper start-up procedures and for avoidance of mechanical impact to the C-arm. A start Up caution label was included with the notification. Further information available at 800-874-7378.

    Distribution

    Nationwide, including AK, KY, NC, VA WA. and WI

    Quantity

    606 units