BEUDAMED
    FDA Recall Terminated

    Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

    Recall: Z-0976-2007 · Initiated November 16, 2005

    Recall

    Recall Number
    Z-0976-2007
    Event Number
    37651
    Firm
    General Electric Med Systems LLC
    Product Code
    IZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 16, 2005
    Posted
    June 28, 2007
    Terminated
    February 24, 2008
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

    Reason

    GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.

    Action

    A Product Safety Notification, dated 05/24/07, was sent to Hospital Administrators, Managers of Radiology and Radiologists. This letter describes the safety issue, instructions to continue the use of the product and states that the device will be corrected by GE Healthcare service engineers.

    Distribution

    Worldwide, including USA, Germany, France, Italy, South Africa, Finland, Norway, Sweden, Venezuela, Benelux, Japan, China, and the UK.

    Quantity

    106