BEUDAMED
    FDA Recall 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 · Initiated September 15, 2014

    Recall

    Recall Number
    Z-0841-2015
    Event Number
    69660
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    September 15, 2014
    Posted
    January 13, 2015
    Terminated
    May 20, 2015
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    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).

    Action

    Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will, without charge, perform a mA calibration on all affected systems in the USA to bring the product back into compliance. The details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. Should customers have any questions or concerns regarding these corrections, please do not hesitate to contact the service team for further information at 800-874-7378 option 8.

    Distribution

    Worldwide Distribution

    Quantity

    61 units installed in US