BEUDAMED
    FDA Enforcement Class II Terminated

    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.

    Recall: Z-0194-2015 · Reported November 19, 2014

    Enforcement

    Recall Number
    Z-0194-2015
    Event ID
    69474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2014
    Initiation Date
    October 3, 2014
    Classification Date
    November 7, 2014
    Termination Date
    March 23, 2015
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States

    Description

    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.

    Reason

    GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

    Code Info

    Serial No: 3120PU3, 4851PU2, 5640PU8, 6052PU5, FIB0064

    Distribution

    Worldwide Distribution.

    Quantity

    5