BEUDAMED
    FDA Enforcement Class I Ongoing

    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

    Recall: Z-0162-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0162-2026
    Event ID
    97750
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IMPRIS Imaging Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 5, 2025
    Initiation Date
    September 30, 2025
    Classification Date
    October 28, 2025
    Address
    1230 Chaska Creek Way Ste 100, N/A, Chaska, MN, 55318-2707, United States

    Description

    IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

    Reason

    There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

    Code Info

    IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.

    Quantity

    N/A