Medical device recalls Moderate risk

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

Recall date
October 16, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0327-2026
FDA classification
Class II
Brand / firm
Canon Medical System, USA, INC.
Sold / distributed
US distribution to Ohio and Nevada

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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