Recall Z-0327-2026 ยท LNH System, Nuclear Magnetic Resonance Imaging
Canon Medical System, USA, INC.
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
| Date | Oct 24, 2025 (initiated Oct 16, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 2 units |
| Distribution | US distribution to Ohio and Nevada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation, Jan 7, 2025 |