IMPRIS Imaging Inc: Device Recall
Recall #Z-0162-2026 · 09/30/2025
Recall Details
- Recall Number
- Z-0162-2026
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- IMPRIS Imaging Inc
- Status
- Ongoing
- Date Initiated
- 09/30/2025
- Location
- Chaska, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Product Description
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Other Recalls by IMPRIS Imaging Inc
- Class I: Dangerous 09/30/2025
- Class I: Dangerous 09/30/2025
- Class I: Dangerous 09/30/2025