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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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