BEUDAMED
    FDA Recall Terminated

    GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy.

    Recall: Z-1883-2008 · Initiated January 2, 2008

    Recall

    Recall Number
    Z-1883-2008
    Event Number
    49487
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 2, 2008
    Posted
    September 25, 2008
    Terminated
    December 10, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy.

    Reason

    Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required

    Action

    GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.

    Distribution

    AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,

    Quantity

    668 (419 US / 249 OUS)