BEUDAMED
    FDA Recall Terminated

    DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.

    Recall: Z-2008-2008 · Initiated March 10, 2008

    Recall

    Recall Number
    Z-2008-2008
    Event Number
    48137
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 10, 2008
    Posted
    September 5, 2008
    Terminated
    December 10, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system.

    Reason

    GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.

    Action

    Field Modification Instructions (FMI No: 40815) will be issued to the field for the DST-XL product to install an arm or gantry rotation motor's brake. The customers letters "Product Safety Notification" dated March 10, 2008, have been distributed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter informs the customers of the safety issue, affected product, safety instructions, product correction and contact information. If you have questions, please contact GE Healthcare within the US or Canada at 1-800-437-1171 or outside the US the telephone number at 1-262-896-2890.

    Distribution

    AL, AR, CA , CO, DE , FL, IA, IL, KS, MA, MI, MS, NC , NJ, NY, OH, OK, PA , SC, TN, TX , VA, VT, WA United Kingdom, Belgium, Switzerland, Russia Federal Sweden, France, Italy, Spain, Germany Federal, Norway, Portugal, Netherlands, Saudi Arabia, Iran, India, Canada, Argentina, Taiwan, China, Bangladesh, Austria.

    Quantity

    127