BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution Apex, Revolution CT with Apex Edition

    Recall: Z-0815-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0815-2022
    Event ID
    89762
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    June 30, 2021
    Classification Date
    April 5, 2022
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Revolution Apex, Revolution CT with Apex Edition

    Reason

    The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

    Code Info

    Revolution Apex, Revolution CT with Apex Edition

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    273 (51 US, 222 OUS) in total