Z-0164-2026 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2025
- Initiation Date
- September 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Code Information
IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806