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 System
- Model numbers
- Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041 MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708 MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894 MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175 MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314 MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354 MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719 MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553 MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579 MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918 MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122 MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387 MRT-3010/A5 MEXL-3010/A5 A5B11Y2005 351452 MRT-3010/A5 MEXL-3010/A5 A5C1262013 356865 MRT-3010/A5 MEXL-3010/A5 A5C1292015 378015 MRT-3010/A5 MEXL-3010/A5 A5C1412028 383946 MRT-3010/A5 MEXL-3010/A5 A5E1522033 389630 MRT-3010/A5 MEXL-3010/A5 A5D1362021 390397
- 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 TITAN 3T is an MRI system used for medical imaging. Hospitals and clinics use it for diagnosing various conditions through detailed imaging.
Why This Is Dangerous
Ice formation in the venting system can lead to a dangerous pressure build-up if helium gas cannot escape properly. This poses a risk of helium release into the scanning room.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate cessation of use of the affected devices, impacting medical facilities and patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your MRI system.
- Check the UDI-DI code against the recalled models.
- Contact Canon Medical Systems for verification.
Where to find product info
The model number and UDI-DI code can typically be found on the back or side of the MRI system.
What timeline to expect
Expect a response regarding refunds or replacements after contacting Canon Medical Systems, typically within a few weeks.
If the manufacturer is unresponsive
- Follow up with Canon Medical Systems via phone or email.
- Document all correspondence related to the recall.
How to prevent similar issues
- Look for FDA recalls when purchasing medical devices.
- Check for safety certifications during procurement.
Documentation advice
Keep a record of your communications with Canon Medical Systems and any relevant documentation regarding the MRI system.
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Product Details
The recalled models are VANTAGE TITAN 3T Model MRT-3010/MEXL-3010. The UDI-DI code is 04987670101649. These systems were distributed nationwide in states including CA, CO, FL, and TX.
Key Facts
- 22 MRI systems recalled
- Potential ice formation in venting system
- Stop using affected devices immediately
- Contact Canon Medical Systems for guidance
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Safety Guide
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