Home / Recalls / Canon Medical System, USA, INC. / Z-1018-2026

Z-1018-2026 Class II Ongoing

Recalled by Canon Medical System, USA, INC. — Tustin, CA

Recall Details

Product Type
Devices
Report Date
January 21, 2026
Initiation Date
December 19, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 systems

Product Description

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

Reason for Recall

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.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.

Code Information

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

Other recalls by Canon Medical System, USA, INC.

  • Z-1017-2026 Class II — VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 (December 19, 2025)
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  • Z-1176-2026 Class II — Alphenix INFX-8000C, interventional fluoroscopic x-ray system (December 19, 2025)
  • Z-1178-2026 Class II — Alphenix INFX-8000H, interventional fluoroscopic x-ray system (December 19, 2025)
  • Z-1179-2026 Class II — Alphenix INFX-8000V, interventional fluoroscopic x-ray system (December 19, 2025)
  • Z-0327-2026 Class II — VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. (October 16, 2025)
  • Z-0037-2026 Class II — This device is a digital radiography/fluoroscopy system used in a diagnostic an (September 2, 2025)
  • Z-0284-2025 Class II — Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a dia (September 17, 2024)
  • Z-2041-2024 Class II — MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-152 (May 10, 2024)
  • Z-1248-2024 Class II — MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 (January 29, 2024)