BEUDAMED
    FDA Enforcement Class II Terminated

    GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.

    Recall: Z-1789-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1789-2012
    Event ID
    37654
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    General Electric Med Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    May 31, 2006
    Classification Date
    June 8, 2012
    Termination Date
    July 31, 2012
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.

    Reason

    An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

    Code Info

    All serial numbers

    Distribution

    Worldwide Distribution.

    Quantity

    3,796 units