VANTAGE GALAN 3T — Class II medical device recall Z-0327-2026
Ongoing recall by Canon Medical System, USA, INC., reported 2025-11-05, distributed in NV, OH. Affected system contains components that do not meet the required distance between electrodes for compliance w
| Recall number | Z-0327-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2025-10-16 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Distributed | NV, OH |
| Quantity | 2 units |
| Serial numbers | B7A2462002, B7A2522014 |
| Model numbers | MEXL-3020/B7, MRT-3020/U7 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0327-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.