BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

    Recall: Z-2152-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2152-2026
    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 Plus, X-ray Computed Tomography, Model Number 5590000-25

    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: 00195278502179; Serial Numbers: REV282400012CN REV282400006CN REV282400038CN REV282400011CN REV282400003CN REV282400013CN REV282300006CN REV282400021CN REV282300013CN REV282400035CN REV282300022CN

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    11 units