BEUDAMED
    FDA Recall Terminated

    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

    Recall: Z-0683-2007 · Initiated March 1, 2007

    Recall

    Recall Number
    Z-0683-2007
    Event Number
    37498
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2007
    Posted
    September 28, 2007
    Terminated
    May 1, 2012
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

    Reason

    During routine service, primary and/or secondary collimators may not have been properly reinstalled.

    Action

    Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.

    Distribution

    Nationwide and Germany.

    Quantity

    1