BEUDAMED
    FDA Enforcement Class I Ongoing

    MAGNETOM Cima.X Upgrade. Model Number: 11689304.

    Recall: Z-0431-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0431-2026
    Event ID
    97845
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2025
    Initiation Date
    October 1, 2025
    Classification Date
    November 12, 2025
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    MAGNETOM Cima.X Upgrade. Model Number: 11689304.

    Reason

    There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    Code Info

    Model Number: 11689304. UDI: (01)04056869975245(21)237304. Serial Number: 237304.

    Distribution

    US distribution to California. International distribution to Australia, Germany, Great Britian.

    Quantity

    4 system (1 US; 3 OUS)