MRI systems recalled over electrode spacing below the required safety standard
Canon Medical Systems is recalling two Vantage Galan 3T MRI systems because components do not meet the required distance between electrodes for IEC 60601-1 compliance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites non-compliance with an electrical safety standard without describing a defect consequence or reported harm.
Plain-English summary
The Canon VANTAGE GALAN 3T, CMSC model MRT-3020/U7, model number MEXL-3020/B7, is being recalled.
The affected systems contain components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.
The recall covers 2 units, serial numbers B7A2462002 and B7A2522014, distributed in Ohio and Nevada. The FDA has classified the action as Class II.
The enforcement record identifies the standards non-compliance without describing a health consequence, and reports no injuries. Sites operating an affected system should follow the firm's instructions.
The recalled product
- Product
- VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
- Manufacturer
- Canon Medical System, USA, INC.
- Category
- Medical Device — MRI system
- Hazard
- standards-noncompliance
- electrical-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Serial Numbers: B7A2462002
- B7A2522014.
Distribution
Distribution scope not specified by the agency.
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