BEUDAMED
    FDA Enforcement Class II Terminated

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    Recall: Z-0841-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0841-2015
    Event ID
    69660
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    September 15, 2014
    Classification Date
    January 12, 2015
    Termination Date
    May 20, 2015
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862, United States

    Description

    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    Reason

    mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).

    Code Info

    GE OEC Brivo 865 Plus Serial Numbers: B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4

    Distribution

    Worldwide Distribution

    Quantity

    61 units installed in US