Reported Nov 5, 2025 · Ongoing

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

Canon Medical System, USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047

Is this the product you have?

  • VANTAGE GALAN 3T
  • CMSC ModelMRT-3020/U7
  • Model NumberMEXL-3020/B7
Lot codes and dates
  • CMSC ModelMRT-3020/U7
  • Model NumberMEXL-3020/B7
  • Serial Numbers
    • B7A2462002
    • B7A2522014
Amount recalled
2 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.