[pending] VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Pending LLM rewrite. Source: FDA_DEVICE Z-1018-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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