Canon Medical System, USA, INC. recalls 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.

Cannon Medical began notifying consignees via email on about 10/16/2025. Consignees were instructed that a representative of Canon Medical Systems USA will contact them to schedule a time to replace the relevant parts. If the message "Gradient power supply error is displayed before the replacement is performed, immediately stop using the system and contact your service representative. Consignees were requested to complete and return the provided response form

• FDA enforcement recordOfficial FDA database entry for Z-0327-2026
• FDA 510(k) clearance · K243335The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Canon Medical System, USA, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.