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Canon Medical System, USA, INC.: VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Medical DevicesSource: FDA (device) · Date: 2025-11-05

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Canon Medical System, USA, INC.
Product
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to Ohio and Nevada
Recall initiated
2025-10-16
Code info
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Product quantity
2 units
Voluntary mandated
Voluntary: Firm initiated
City
Tustin
State
CA
Country
United States
Event id
97735
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