BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2151-2026 · Initiated March 26, 2026

    Recall

    Recall Number
    Z-2151-2026
    Event Number
    98738
    Firm
    GE Medical Systems, LLC
    FEI Number
    2126677
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 26, 2026
    Posted
    May 8, 2026
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notification letter dated 3/26/26 was sent to customers. Actions to be taken by Customer/User Pending corrections by GE HealthCare, you can continue to use your system by following security and cybersecurity best practices. Before the interim solution (see Product Correction section below) is applied, please follow the instructions below as identified in the respective CT system User Manuals: CAUTION: 3D or slab reconstructions provide additional supplemental information, complementing diagnosis that should be based on classical techniques. WARNING: Do not use 3D or slab views only to perform any measurements (distance, angle, region of interest, report cursor, area, volume, etc.). Always check measurement points position and refer to 2D baseline views (acquisition images or reformatted images of minimal thickness) to confirm measurements. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form electronically via (https://gehealthcare-svc.my.site.com/publicForm/s/?formId=aGjUr000002jnD7) or print, fill out manually, scan and email to [email protected] Product Correction GE HealthCare will correct all affected products at no cost to you in two steps. A GE HealthCare representative will contact you to arrange for an interim solution to deactivate AW Server authentication through the CT system on the EHL-based Smart Subscription, and later, to install a CT software update. Note: With the interim solution, all alternative authentication mechanisms (direct application launch from CT console user interface, login using users defined in AW Server user database, federation with hospital user directory through LDAP) will remain available. Contact Information If you have any questions or concerns regarding this notification, please contact GE HealthCare

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    33 units