BEUDAMED
    FDA Recall Terminated

    Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.

    Recall: Z-0588-06 · Initiated January 26, 2006

    Recall

    Recall Number
    Z-0588-06
    Event Number
    34935
    Firm
    General Electric Med Systems LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2006
    Posted
    June 2, 2006
    Terminated
    December 27, 2006
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.

    Reason

    The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

    Action

    All affected customers are being sent an 'Important Radiation Safety Notification' letter dated November 10, 2005, that identifies affected units, the associated potential hazards, and the planned modification. A Copy of the Technical Reference Manual will be included with the customer letter.

    Distribution

    Nationwide, Worldwide. AL, CA, CT, FL, IN, MA, MD, MN, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, Puerto Rico. OUS to include: Austria, Brazil, Canada, China, Columbia, Egypt, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, United Kingdom, Venezuela

    Quantity

    74