VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
- Company
- Canon Medical System, Usa, Inc.
- Recall Initiated
- October 16, 2025
- Posted
- October 24, 2025
- Recall Number
- Z-0327-2026
- Quantity
- 2 units
- Firm Location
- Tustin, CA
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
Lot / Code Info
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Root Cause
Device Design
Action Taken
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