FDA Medical devices recall ·
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0161-2026
- Date
- (initiated September 30, 2025)
- Company / brand
- IMPRIS Imaging Inc
1230 Chaska Creek Way Ste 100, Chaska, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0161-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.