IMPRIS Imaging Inc: IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- IMPRIS Imaging Inc
- Product
- IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
- Reason / hazard
- 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
- Recall initiated
- 2025-09-30
- Code info
- IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Chaska
- State
- MN
- Country
- United States
- Event id
- 97750
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