FDA Medical devices recall ·
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7 recall
- Recall number
- Z-0327-2026
- Date
- (initiated October 16, 2025)
- Company / brand
- Canon Medical System, USA, INC.
2441 Michelle Dr, Tustin, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Distribution
US distribution to Ohio and Nevada
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0327-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.