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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

Canon Medical System, USA, INC.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1017-2026
Classification
Class II
Recalled
December 19, 2025
Read the official notice

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