FDA recall, , Moderate risk
Canon Medical Vantage Galan 3T and Vantage Titan 3T MRI Systems
If a quench occurs, helium gas may not escape, and pressure in the helium vessel may rise.
Summary by Recall Canary from the FDA notice
What happened
Canon Medical System, USA, INC., of Tustin, California, is recalling certain Vantage Titan 3T and Vantage Galan 3T MRI systems because of a potential for ice formation in the venting system of the superconducting magnet.
If a quench occurs in this condition, helium gas may not escape via the designed vent paths, and pressure in the helium vessel may rise, possibly rupturing the vessel and releasing helium gas into the MR scanning room. The recall began on December 19, 2025, and was added to the FDA's Enforcement Report on January 13, 2026.
The affected systems are the Vantage Titan 3T Model MRT-3010/MEXL-3010 and the Vantage Galan 3T Model MRT-3020/MEXL-3020, distributed nationwide in states including California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, and Wisconsin.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Vantage Titan 3T Model MRT-3010/MEXL-3010
- UDI-DI
- 04987670101649
- 30000041
- 30001708
- 30005894
- 30007620
- 30019175
- 30024266
- 30027318
- 30029482
- 30050314
Vantage Galan 3T Model MRT-3020/MEXL-3020
- UDI-DI
- 04987670102615
- 30058153
- 30075456
- 30097122
- 30047848
- 30102813
- 30108012
- 30100563
- 30060527
- 30064817
- 30069306
- 30071480
- 30072643
- 30085151
- 30098384
- 30100803
- 30109383
- 30007763
- 30031740
- 30034832
- 30036503
- 30040917
- 30041962
- 30042870
- 30043510
- 30053897
- 30056987
- 30087647
- 30087649
- 30092401
- 30056208
- 30044596
- 30081608
- 30094084
- 30119571
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, PR, Texas, Virginia, and Wisconsin.
- Company
- Canon Medical System, USA, INC.Tustin, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98112
- Recall numbers
- Z-1017-2026 to Z-1018-2026
All recalls from Canon Medical System, USA, INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
