VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Reported: November 5, 2025 Initiated: October 16, 2025 #Z-0327-2026
Product Description
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
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.
Details
- Recalling Firm
- Canon Medical System, USA, INC.
- Units Affected
- 2 units
- Distribution
- US distribution to Ohio and Nevada
- Location
- Tustin, CA
Frequently Asked Questions
What product was recalled? ▼
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.. Recalled by Canon Medical System, USA, INC.. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0327-2026.
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