BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

    Recall: Z-2154-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2154-2026
    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, X-ray Computed Tomography, Model Number 5590000-20

    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: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    24 units