IMPRIS Imaging Inc medical device recall: IMRIS Operating Suite
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97750
- Recall initiated
- Sep 30, 2025
- Classified by FDA
- Oct 28, 2025
- Posted in Enforcement Report
- Nov 5, 2025
- Recalling firm
- IMPRIS Imaging Inc
- Firm location
- Chaska, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 30, 2025. FDA classified it 28 days later, on Oct 28, 2025. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Recalled products (4)
Z-0161-2026 Class I Ongoing
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Codes / lots: IMRIS Part Number(s): 105118-000, UDI/DI None predates UDI; 105118-001, UDI/DI None predates UDI; 105117-003, UDI/DI None predates UDI; 105117-004, UDI/DI None predates UDI; 105048-000, UDI/DI None predates UDI; 105048-001, UDI/DI None predates UDI; 105103-001, UDI/DI None predates UDI; 105071-004, UDI/DI None predates UDI; 105824-000, UDI/DI 00857534006189; 105828-000, UDI/DI 00857534006165; 116189-000, UDI/DI 00857534006202; 118396-000, UDI/DI 00857534006196.
Z-0162-2026 Class I Ongoing
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
Codes / lots: IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.
Z-0163-2026 Class I Ongoing
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Codes / lots: IMRIS Part Number(s): 120823-000, UDI/DI 00857534006745
Z-0164-2026 Class I Ongoing
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Codes / lots: IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97750
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.