BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1638-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1638-2015
    Event ID
    71298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE OEC Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 22, 2014
    Classification Date
    June 8, 2015
    Termination Date
    June 24, 2015
    Address
    384 N Wright Brothers Dr, N/A, Salt Lake City, UT, 84116-2862, United States

    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.

    Code Info

    OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.

    Distribution

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

    Quantity

    9