VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
FDA device recall Z-0327-2026 · posted 2025-10-24 · Open, Classified
Recall details
- Recalling firm
- Canon Medical System, USA, INC.
- 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.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 2 units
- Distribution
- US distribution to Ohio and Nevada
- Date initiated
- 2025-10-16
- Date posted
- 2025-10-24
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) | Canon Medical Systems Corporation | 2025-01-07 |