BEUDAMED
    FDA Recall Terminated

    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)

    Recall: Z-1638-2015 · Initiated May 22, 2014

    Recall

    Recall Number
    Z-1638-2015
    Event Number
    71298
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 22, 2014
    Posted
    June 8, 2015
    Terminated
    June 24, 2015
    Address
    384 N Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)

    Reason

    Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.

    Action

    GE Healthcare Surgery Planned Action(s) to repair the defect or to bring the product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 9 units consisted of the following: 1. Replacing the tube side cover with the laser aimer assembly with a tube side cover without a laser aimer assembly. This correction brought the systems into compliance with applicable US regulations. For further questions please call (801) 536-4615.

    Distribution

    US Distribution to the states of: MD, NC, MT, NJ, UT and NY

    Quantity

    9