VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number:… recallZ-0327-2026 · Canon Medical System, USA, INC. · initiated Oct 16, 2025
Class II Open, Classified All recalls posted in October 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-0327-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Oct 16, 2025
- Posted by the FDA
- Oct 24, 2025
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 2 units
- Product code
- LNH
- FDA submissions
- K243335
- Distribution
- US distribution to Ohio and Nevada
Product description
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Code information (models, lots, serial numbers)
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Other devices under the same FDA submission
1 device cleared under K243335 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vantage Galan 3T MRT-3020Canon Inc. · System, nuclear magnetic resonance imaging2 recalls3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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