BEUDAMED
    FDA Enforcement Class II Terminated

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    Recall: Z-0840-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0840-2015
    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 715 Prime 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 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6

    Distribution

    Worldwide Distribution

    Quantity

    61 units installed in US