HIGH

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Systems recalled 22 MRI systems on December 19, 2025, due to a potential ice formation hazard in the venting system. The defect could lead to a pressure build-up and helium gas release. Healthcare providers must stop using the affected devices immediately.

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

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

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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.

The Hazard

The venting system of the superconducting magnet may form ice. If a quench occurs, helium gas may not escape, causing pressure to rise and potentially rupture the helium vessel.

Reported Incidents

No injuries or incidents have been reported to date related to this defect. The recall is classified as Class II, indicating a moderate risk.

What to Do

Healthcare providers should stop using the affected MRI systems immediately. Follow the manufacturer's recall instructions and contact Canon Medical Systems for further guidance.

Contact Information

For more information, contact Canon Medical Systems, USA, INC. or visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1018-2026.

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 Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

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
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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