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Recall Observatory FDA recall evidence

Device product

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

Z-0327-2026

October 16, 2025

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 97735
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0327-2026

Official wording

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.

Code information: CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.

Distribution pattern: US distribution to Ohio and Nevada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.