IMRIS Operating Suite — Class I medical device recall Z-0161-2026
Ongoing recall by IMPRIS Imaging Inc, reported 2025-11-05, distributed nationwide. There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system w
| Recall number | Z-0161-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMPRIS Imaging Inc, Chaska, MN, United States |
| Recall initiated | 2025-09-30 |
| Classified | 2025-10-28 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, JP, QA, SE |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00857534006165, 00857534006189, 00857534006196, 00857534006202 |
| Model numbers | 105118-000 |
Product
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0161-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.