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Moderate riskFDA DeviceClass II

Canon Medical VANTAGE TITAN 3T MRI recalled for potential helium vessel rupture

Ice can form in the venting system of Canon Medical VANTAGE TITAN 3T MRI machines (models MRT-3010/MEXL-3010). If the system undergoes a quench event while ice is present, helium gas may not escape properly and pressure inside the helium vessel could build up and rupture, releasing helium gas into the scanning room.

From the FDA notice · Read the official notice ↗ · All Canon recalls

What to do

  1. Check if your facility has one of the 22 affected MRI systems using the model and serial numbers provided
  2. Contact Canon Medical USA for inspection and remediation instructions
  3. Do not operate the system until you receive guidance from Canon Medical
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
22 systems
Illnesses reported
None reported
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Classification
Class II
Recall number
Z-1018-2026

In the FDA's words

Description
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 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. 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 Distribution: 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. Affected quantity: 22 systems
Hazard
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.

2 products in this recall

Canon Vantage MRI systems recalled for helium release risk

Canon is recalling 2 Vantage 3T MRI models, with 56 systems affected in total. Ice can form in the venting system of the superconducting magnet, so if a quench occurs, helium gas may not escape through its vent paths, and pressure in the helium vessel can rise. This could eventually rupture the vessel and release helium gas into the MR scanning room. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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