FDA-Device2026-01-21Class IIPROCESSING DEFECT

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

OTHERNationwide distributionMedical devices

What this means

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.

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

The agency's original wording

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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 count

22 systems

Manufactured in

2441 Michelle Dr, Tustin, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2026

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