Canon VANTAGE GALAN 3T MRI Recall
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Updated December 19, 2025
Canon Medical's VANTAGE GALAN 3T MRI machines may develop ice in the magnet venting system. During an emergency shutdown (quench), helium gas could become trapped and build pressure, potentially rupturing the vessel and releasing helium into the scanning room.
Is the Canon Medical System, USA, INC. recalled? Yes. This product was recalled by FDA on December 19, 2025. Details below.
What is recalled
Canon Medical System, USA, INC. VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 MRI systems.
Am I affected
You're affected if your facility owns or operates a Canon VANTAGE GALAN 3T MRI system, Model MRT-3020 or MEXL-3020.
What to do right now
Contact Canon Medical System, USA, INC. immediately to discuss this issue. Do not operate the device until you have received guidance from the manufacturer on the ice formation hazard and any required corrective action.
The 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.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1017-2026
- Classification
- Class II
- Recalled
- December 19, 2025
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