FDAFDA · Food and drugs·Recall number Z-0327-2026
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Published November 5, 2025 · Recall initiated: October 16, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- US distribution to Ohio and Nevada
- Lot
- CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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