BEUDAMED
    FDA Recall Terminated

    GE Healthcare Definium 8000 Digital Radiographic System.

    Recall: Z-1882-2008 · Initiated March 7, 2008

    Recall

    Recall Number
    Z-1882-2008
    Event Number
    49503
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 7, 2008
    Posted
    September 25, 2008
    Terminated
    January 7, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Definium 8000 Digital Radiographic System.

    Reason

    Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea

    Action

    GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.

    Distribution

    Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.

    Quantity

    454 (277 US / 177 OUS)