Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Canon Medical System, USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Canon Medical System, USA
- Product type
- MRI Systems
- Model numbers
- Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012 MRT-3020/A5 MEXL-3020/D5 D5A2062003 30053897 (01)04987670102615(21)A5D2062015 MRT-3020/A5 MEXL-3020/S5 S5C18Y2048 30056987 (01)04987670102615(21)A5C18Y2013 MRT-3020/A5 MEXL-3020/D5 D5D23X2032 30087647 (01)04987670102615(21)A5G23X2017 MRT-3020/A5 MEXL-3020/D5 D5C2292024 30087649 (01)04987670102615(21)A5F2292016 MRT-3020/A5 MEXL-3020/S5.004 S5A1662001 30092401 (01)04987670102615(21)A5A1662001 MRT-3020/A6 MEXL-3020/D7 D7B2152015 30056208 (01)04987670102615(21)A6D2152001 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 (01)04987670102615(21)A7B1892001 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 (01)04987670102615(21)A7D2182004 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 (01)04987670102615(21)A7B1962002 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571 (01)04987670102615(21)A7B1992003 MRT-3020/A7 MEXL-3020/S7 S7B1892004 30044596 MRT-3020/A7 MEXL-3020/D7 D7B2182017 30081608 MRT-3020/A7 MEXL-3020/S7.007 S7B1962013 30094084 MRT-3020/A7 MEXL-3020/S7.007 S7B1992017 30119571
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Canon Medical System, USA, INC. or your healthcare provider for instructions. Notification method: Letter
About This Product
The VANTAGE GALAN 3T MRI systems are advanced imaging devices used in hospitals and clinics for diagnostics. These systems are essential in providing high-quality imaging for patients.
Why This Is Dangerous
The venting system in the superconducting magnet may form ice, leading to a dangerous pressure build-up if a quench occurs. This can result in a rupture of the helium vessel, releasing helium gas.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers must stop using these MRI systems immediately, affecting diagnostic services and potentially delaying patient care.
Practical Guidance
How to identify if yours is affected
- Check the model number of your MRI system.
- Verify if it is one of the affected models: MRT-3020 or MEXL-3020.
- Consult the UDI-DI code for confirmation.
Where to find product info
Look for the model number and UDI-DI code on the manufacturer's label attached to the MRI system.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Document your communication attempts.
- Contact the FDA if the manufacturer does not respond.
- Consider legal advice if safety concerns persist.
How to prevent similar issues
- Choose MRI systems with updated safety features.
- Stay informed about recalls and safety notices for medical devices.
Documentation advice
Keep records of your purchase, any communication with the manufacturer, and documentation of the recall.
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Product Details
The recall involves VANTAGE GALAN 3T MRI systems, models MRT-3020 and MEXL-3020. These units were distributed nationwide in California, Colorado, Florida, and other states. The systems were sold primarily to healthcare providers.
Key Facts
- 34 MRI systems recalled
- Risk of helium gas release
- Stop using devices immediately
- No reported injuries or incidents
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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