VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 19, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | Canon Medical System, USA, INC. |
| Country / region | United States CA |
Hazard
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Affected products
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
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