BEUDAMED
    FDA Enforcement Class II Completed

    Revolution CT

    Recall: Z-2004-2021 · Reported July 14, 2021

    Enforcement

    Recall Number
    Z-2004-2021
    Event ID
    88150
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    July 14, 2021
    Initiation Date
    March 19, 2021
    Classification Date
    July 8, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Revolution CT

    Reason

    GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

    Code Info

    5590000 5590000-6 5590000-2

    Distribution

    Worldwide distribution - US Nationwide

    Quantity

    197 (US = 40; OUS = 157)