Medical Device Recall: VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA, INC. · December 19, 2025
Reason for Recall
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.
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.
States Affected
NATIONWIDE
Quantity Affected
34 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1017-2026
Status: ongoing
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