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.
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.
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.
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.
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.
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.
Identify the model number on your Vantage Galan 3T system to see if it matches MRT-3020/U7 or MEXL-3020/B7.
The system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
The recall record does not specify a remedy, so contact Canon Medical directly for guidance.
Yes, serial numbers B7A2462002 and B7A2522014 are listed as affected.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0327-2026 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-0327-2026 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
