BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0162-2026 · Initiated September 30, 2025

    Recall

    Recall Number
    Z-0162-2026
    Event Number
    97750
    Firm
    IMPRIS Imaging Inc
    FEI Number
    3010326005
    Product Code
    LNH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 30, 2025
    Posted
    October 28, 2025
    Address
    1230 Chaska Creek Way, Ste 100, Chaska, MN, 55318-2707

    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.

    Action

    Imris issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 9/30/2025 via email. The notice explained the issue, the risk to health, and provided the following information: "If the error message, "Magnet Supervision: The average heater power is above the alarm threshold. Please contact Siemens Service." appears, DO NOT REBOOT THE SYSTEM. Please call your local Siemens Healthineers service organization. Grant access to the system so that the inspection can be carried out as directed by Siemens Healthineers service organization." "Please immediately instruct your personnel accordingly, and please contact our customer support team via our service line at 1-866-475-0525 or e-mail at [email protected] if you have any questions or concerns. Please keep this information until the corrective measures have been finalized." This notice included a copy of the Siemens Healthineers Urgent Medical Device Correction notice.

    Distribution

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