IMRIS recalls iMRI 3T S MRI systems with Siemens 3T Skyra magnet due to potential helium leak risk from magnet venting system ice blockage.
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.
IMRIS is recalling its iMRI 3T S MRI systems that contain Siemens 3 Tesla Skyra magnets. The recall is because ice blockage in the magnet venting system could cause helium to leak into the scanning room during a quench event.
Ice blockage in the magnet venting system could prevent helium from escaping during a quench event. This might cause pressure buildup that ruptures the helium containment system, leading to helium leaks in the scanning room.
Medical facilities using IMRIS iMRI 3T S systems with Siemens 3T Skyra magnets are affected. Patients and staff in these facilities face the risk of helium leaks during magnet quench events.
Check for IMRIS part numbers 116053-000, 116117-000, 116118-000, or 116119-000 with UDI/DI codes 00857534006035, 00857534006042, 00857534006059, or 00857534006066.
Verify your IMRIS iMRI 3T S system has one of the listed part numbers or UDI/DI codes.
The recall is due to a potential ice blockage in the magnet venting system that could cause helium leaks during a quench event.
If the magnet venting system freezes, helium could build up pressure and rupture, causing helium leaks in the scanning room.
Check for IMRIS part numbers 116053-000, 116117-000, 116118-000, or 116119-000 with UDI/DI codes 00857534006035, 00857534006042, 00857534006059, or 00857534006066.
We’ve drafted a message you can send IMRIS to request your refund or repair — edit it as you like.
Subject: Recall Z-0162-2026 — IMRIS IMRIS Hello, I own a IMRIS that is covered by recall Z-0162-2026 from IMRIS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
