IMPRIS Imaging Inc — IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 30, 2025
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
What's affected?
- Product
- IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
- Brand
- IMPRIS Imaging Inc
- Lot code
- IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.
Additional details
IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: N/A.
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