Reported Jan 21, 2026 · Ongoing
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
- Lot codes and dates
- Model NumberMRT-3010/MEXL-3010
- UDI-DI code04987670101649 CMSC Model Number/Model
- Number/Serial Numbers/SID/UDI code(01)04987670101649(21)A5G1692039
MRT-3010/A5MEXL-3010/A5A5D14X203130000041MRT-3010/A5MEXL-3010/A5A5D13Y202530001708MRT-3010/A5MEXL-3010/A5A5D13Y202630005894MRT-3010/A5MEXL-3010/A5A5G169203930007620
(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)A5G1642036MRT-3010/A5MEXL-3010/A5.007A5B11Y200630019175MRT-3010/A7MEXL-3010/S7S7A164200630024266
MRT-3010/A5MEXL-3010/A5.007A5F156203430050314MRT-3010/A5MEXL-3010/A5A5B11Z2007303354MRT-3010/A5MEXL-3010/A5A5C1252012336719MRT-3010/A5MEXL-3010/A5A5D1312019350553MRT-3010/A5MEXL-3010/A5A5B1192003350579MRT-3010/A5MEXL-3010/A5A5C12X2016350918MRT-3010/A5MEXL-3010/A5A5C12Y2017351122MRT-3010/A5MEXL-3010/A5A5C1212009351387MRT-3010/A5MEXL-3010/A5A5B11Y2005351452MRT-3010/A5MEXL-3010/A5A5C1262013356865MRT-3010/A5MEXL-3010/A5A5C1292015378015MRT-3010/A5MEXL-3010/A5A5C1412028383946MRT-3010/A5MEXL-3010/A5A5E1522033389630MRT-3010/A5MEXL-3010/A5A5D1362021390397
- Amount recalled
- 22 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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