VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Reported: January 21, 2026 Initiated: December 19, 2025 #Z-1017-2026
Product Description
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
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.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 34 systems
- 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.
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020. Recalled by Canon Medical System, USA, INC.. Units affected: 34 systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1017-2026.
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