FDAHealthOctober 16, 2025

Canon Medical System, USA, INC. — VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

⚠️ 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.

Is this relevant to me?

Geography: US
Source agency: FDA
Category: Health
Published: October 16, 2025

US distribution to Ohio and Nevada

What's affected?

Product: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Brand: Canon Medical System, USA, INC.
Lot code: CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

Additional details

CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.

View original FDA notice →

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