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Canon Medical System, USA, INC. Recall

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

Updated December 19, 2025

Canon Medical System, USA, INC. is recalling VANTAGE GALAN 3T Model MRT-3020/MEXL-3020. 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.

Is the Canon Medical System, USA, INC. recalled? Yes. This product was recalled by FDA on December 19, 2025. Details below.

What is recalled

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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
Drugs & Medications
Recall ID
fda-Z-1017-2026
Classification
Class II
Recalled
December 19, 2025
Read the official notice

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