BEUDAMED
    FDA Enforcement Class II Ongoing

    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

    Recall: Z-1300-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1300-2025
    Event ID
    96370
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE Medical Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2025
    Initiation Date
    February 18, 2025
    Classification Date
    March 7, 2025
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

    Reason

    GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

    Code Info

    System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number 973971CTREV, UDI (01)00840682118552(11)160600(21)REVVX1600010CN, Mfg. Lot/Serial Number REVVX1600010CN; System ID Number 513584APEX1, UDI (01)00840682146616(11)230300(21)REV2A2300023CN, Mfg. Lot/Serial Number REV2A2300023CN

    Distribution

    Worldwide distribution.

    Quantity

    4 units