BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

    Recall: Z-2151-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2151-2026
    Event ID
    98738
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2026
    Initiation Date
    March 26, 2026
    Classification Date
    May 8, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

    Reason

    GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    Code Info

    UDI-DI: 00195278460271; Serial Numbers: REV2X2400067CN REV2X2400065CN REV2X2400046CN REV2X2400021CN REV2X2400050CN REV2X2400095CN REV2X2400078CN REV2X2300068CN REV2X2400093CN REV2X2400098CN REV2X2300091CN REV2X2300042CN REV2X2300083CN REV2X2300020CN REV2X2400068CN REV2X2400107CN REV2X2300090CN REV2X2300097CN REV2X2300003CN REV2X2400028CN REV2X2400026CN REV2X2300002CN REV2X2400027CN REV2X2400059CN REV2X2300084CN REV2X2400069CN REV2X2400063CN REV2X2400055CN REV2X2300011CN REV2X2300050CN REV2X2400048CN REV2X2300047CN REV2X2400014CN

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    33 units