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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 2
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
Related recalls
Same manufacturer · Canon Medical System, USA, INC.
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- ModerateAlphenix INFX-8000F systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- ModerateAlphenix INFX-8000H systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- HighQ.namix R fluoroscopy systems recalled over unflipped and mismatched images
FDA (Devices) · 2026-02-04
Similar recalls
- HighCanon Vantage Galan 3T MRI System Recalled for Fire Risk
FDA (Devices) · 2021-07-21
- HighCanon MRI System Recalled for Flame-Retardancy Component Defect
FDA (Devices) · 2021-07-21
- HighMRI systems recalled over ice that may block the magnet venting system
FDA (Devices) · 2026-01-21
- HighMRI Systems Power Cable Terminal Block Fire Hazard Recall
FDA (Devices) · 2024-06-19
- HighMRI System Displays Incorrect Field Gradient Safety Values
FDA (Devices) · 2024-03-13
- HighMRI systems recalled over ice that may block magnet venting
FDA (Devices) · 2026-01-21