Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC
- Recalling company
- Canon Medical System, USA, INC.
- Product
- VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 16, 2025
- Reported
- Nov 5, 2025
- Distribution
- US distribution to Ohio and Nevada
- Status
- Ongoing
- Quantity
- 2 units
- Lot / codes
- CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
- Company location
- Tustin, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0327-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0327-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.