Canon Medical recalls Vantage Titan 3T MRI systems with potential ice formation in venting that could cause helium vessel rupture if a quench occurs. Affected models include MRT-3010/MEXL-3010 with specific serial numbers.
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.
Canon Medical is recalling Vantage Titan 3T MRI systems that may develop ice in the venting system. If a quench occurs, this could cause helium pressure buildup and rupture, releasing helium gas into the scanning room. This poses a risk of injury to people in the MRI room.
Ice can form in the venting system of the MRI's superconducting magnet. If a quench (sudden loss of superconductivity) happens while ice is present, helium gas may not escape properly. This could cause pressure to build up in the helium vessel, potentially rupturing it and releasing helium gas into the MRI room.
Patients and staff using Canon Vantage Titan 3T MRI systems with model numbers MRT-3010 or MEXL-3010. Those most at risk are individuals in the MRI room during a quench event.
Check for model numbers MRT-3010 or MEXL-3010 on the device. Affected units have specific serial numbers listed in the recall notice, including UDI-DI codes like 04987670101649.
Identify if your MRI system has model numbers MRT-3010 or MEXL-3010 as listed in the recall notice.
Reach out to Canon Medical System, USA, INC. for assistance with the recall process.
If ice forms and a quench occurs, helium gas may not escape properly, causing pressure buildup that could rupture the helium vessel and release helium gas into the MRI room.
Check for model numbers MRT-3010 or MEXL-3010 with specific serial numbers listed in the recall notice, including UDI-DI codes like 04987670101649.
No, but you should check if your system is affected and contact Canon for guidance. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Canon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1018-2026 — Canon Medical Canon Medical Hello, I own a Canon Medical that is covered by recall Z-1018-2026 from Canon Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
