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

FDA device recall Z-0162-2026 · posted 2025-10-28 · Open, Classified

Recall details

Recalling firm

IMPRIS Imaging Inc

Reason for recall

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 taken

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 customersupport@imris.com 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LNH

Distribution

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

Date initiated

2025-09-30

Date posted

2025-10-28

Location

Chaska, MN

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