FDA recall Z-0327-2026

Canon Medical System, USA, INC. · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-10-16
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2026