BEUDAMED
    FDA Recall Terminated

    GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.

    Recall: Z-1822-2008 · Initiated March 7, 2008

    Recall

    Recall Number
    Z-1822-2008
    Event Number
    49504
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 7, 2008
    Posted
    September 25, 2008
    Terminated
    December 11, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.

    Reason

    Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover).

    Action

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

    Distribution

    Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.

    Quantity

    127