Class II

Medical Device Recall: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Canon Medical System, USA, INC. · October 16, 2025

Reason for Recall

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.

Distribution

US distribution to Ohio and Nevada

Quantity Affected

2 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0327-2026

Status: ongoing

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