BEUDAMED
    FDA Enforcement Class II Ongoing

    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

    Recall: Z-0855-2021 · Reported January 20, 2021

    Enforcement

    Recall Number
    Z-0855-2021
    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

    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.

    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

    Serial numbers: 87CY63028, 87CZ63044, 87CZ63045, 87CZ63042, 87CY63025, 87CY63029, 87CY63027, 87CY63030, 87CZ63046, 87CY63034, 87CY63032, 87CY63033

    Distribution

    Worldwide

    Quantity

    12 units