CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Vantage Galan 3t recalled by Canon Medical System, USA
Canon Medical System USA is recalling Vantage Galan 3t, distributed in Nevada, Ohio. The recall was initiated on 16 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0327-2026
- FDA event ID
- 97735
- Recalling firm
- Canon Medical System USA, Tustin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Oct 2025
- FDA classified
- 24 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2025 | Recall initiated by company | |
| 24 Oct 2025 | Classified by FDA | +8 days |
| 5 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
Where it was distributed
US distribution to Ohio and Nevada
Questions about this recall
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.
Which lots are affected?
CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002, B7A2522014.
Where was it sold?
US distribution to Ohio and Nevada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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