BEUDAMED
    FDA Enforcement Class II Ongoing

    Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

    Recall: Z-0242-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0242-2022
    Event ID
    89027
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    June 30, 2021
    Classification Date
    November 24, 2021
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

    Reason

    The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

    Code Info

    Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

    Distribution

    Worldwide and US Nationwide Distribution

    Quantity

    105 in total