BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0327-2026 · Initiated October 16, 2025

    Recall

    Recall Number
    Z-0327-2026
    Event Number
    97735
    Firm
    Canon Medical System, USA, INC.
    FEI Number
    2020563
    Product Code
    LNH
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 16, 2025
    Posted
    October 24, 2025
    Address
    2441 Michelle Dr, Tustin, CA, 92780-7047

    Description

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

    Reason

    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.

    Action

    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

    Distribution

    US distribution to Ohio and Nevada

    Quantity

    2 units