Canon Vantage Galan 3T Medical Device Recall: Electrode Distance Risk
Canon Medical recalls Vantage Galan 3T MRI systems with model MRT-3020/U7 and MEXL-3020/B7 due to potential electrode distance issues violating medical safety standards. Affected units may not meet IEC 60601-1 compliance.
Recall notice
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.
Contact the company
What happened, in plain English
Canon Medical is recalling Vantage Galan 3T MRI systems with specific model numbers because their electrical components may not meet safety standards for medical devices. This could pose a risk to patient safety during use. Read more at govinfonow.com/recall/51055-canon-vantage-galan-3t-medical-device-recall-electrode-distance-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51055-canon-vantage-galan-3t-medical-device-recall-electrode-distance-risk · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0327-2026
Cite this page
“Canon Vantage Galan 3T Medical Device Recall: Electrode Distance Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51055-canon-vantage-galan-3t-medical-device-recall-electrode-distance-risk. Based on FDA recall #Z-0327-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0327-2026%22&limit=1).
Why it’s dangerous
The system's electrodes may be too close together, which could violate medical safety standards for electrical equipment. This might cause electrical issues during patient scans, potentially affecting patient safety.
Who’s affected
Patients and medical staff using the recalled Vantage Galan 3T MRI systems with model numbers MRT-3020/U7 and MEXL-3020/B7 are affected. Medical facilities that own these systems are most at risk.
How to tell if you have this one
Check for model numbers MRT-3020/U7 or MEXL-3020/B7 on the device. Serial numbers B7A2462002 and B7A2522014 are also associated with this recall.
- Brand
Canon Medical- Category
Medical device
What to do — step by step
Check Device Model
Identify the model number on your Vantage Galan 3T system to see if it matches MRT-3020/U7 or MEXL-3020/B7.
Where it went and when
Where it was distributed
Distributed in Nevada and Ohio.
FDA distribution: “US distribution to Ohio and Nevada” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Nevada, Ohio.
Recall timeline
FDA published this recall 20 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0327-2026 (October 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0327-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.