Recall archive / FDA device enforcement
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. — FDA record Z-0327-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0327-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Ohio and Nevada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 5, 2025
- Recall initiation date
- Oct 16, 2025
- Center classification date
- Oct 24, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.