BEUDAMED
    FDA Enforcement Class II Ongoing

    Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

    Recall: Z-2149-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2149-2026
    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 Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

    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: 00840682146173; Serial Numbers: AS10G2200136YC AS10G2200101YC AS10G2200068YC AS10G2200035YC AS10G2300093YC AS10G2400094YC AS10G2400079YC AS10G2100008YC AS10G2500002YC CBDWG2400019HM CBDWG2300081HM AS10G2400056YC AS10G2400081YC AS10G2400087YC CBDWG2400117HM CBDWG2400085HM CBDWG2500003HM CBDWG2400140HM CBDWG2400126HM AS10G2200085YC AS10G2300057YC CBDWG2500011HM CBDWG2300056HM CBDWG2300041HM AS10G2300041YC

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    25 units