BEUDAMED
    FDA Enforcement Class II Ongoing

    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

    Recall: Z-0857-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0857-2021
    Event ID
    87023
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2021
    Initiation Date
    December 10, 2020
    Classification Date
    January 13, 2021
    Address
    3000 N Grandview Blvd, N/A, Waukesha, WI, 53188-1615, United States

    Description

    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

    Reason

    GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

    Code Info

    Discovery 670 DR (Model H3100BT), Serial Numbers: DRGY56033, DRGY56037, DRGY56035, DRGY56030, DRGZ56043, DRGZ56042, DRGY56032, DRGY56031, DRGY56034, DRGY56036 NM/CT 870 DR (Model 3100Q), Serial Numbers: 870Y64066, and (Model H3100AS), Serial Numbers: 870Y64077, 870Y64064, 870Y64081, 870Y64079, 870Y64067, 870Y64074, 870Z64117, 870Y64078, 870Y64080, 870Y64069, 870Y64085, 870Z64121, 870Z64119, 870Z64122, 870Y64056, 870Y64063, 870Z64114, 870Z64115, 870Y64068, 870Y64082, 870Z64116, 870Z64120, 870Y64065, 870Y64084, 870Y64061, 870Y64083, 870Z64113, 870Y64070, 870Z64123, 870Y64058, 870Z64118, 870Y64057 Discovery NM670 Pro (Model 3100XB), Serial Numbers: PRGY52027, PRGY52031, PRGZ52047, PRGZ52046, PRGY52028, PRGZ52048, PRGY52029, PRGY52030 Discovery 670 ES (Model H3100XF), Serial Numbers: ESGZ53005

    Distribution

    Worldwide

    Quantity

    52 untits