BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.

    Recall: Z-0716-2008 · Initiated September 28, 2007

    Recall

    Recall Number
    Z-0716-2008
    Event Number
    46349
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2007
    Posted
    March 15, 2008
    Terminated
    November 1, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.

    Reason

    Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

    Action

    On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield.

    Distribution

    Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK.

    Quantity

    157 units (Domestic), 142 units (Foreign)