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Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Recalled November 5, 2025 · FDA recall Z-0327-2026 · Canon Medical System, USA
Hazard
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment. · FDA Class II
Units
2 units
Sold at
US distribution to Ohio and Nevada
Description
Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
Product
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →