Use cautionMedical device recall · FDA · Published December 19, 2025
Canon Medical Vantage Galan 3T MRI Recall: Ice Risk in Superconducting Magnet
Canon Medical recalls Vantage Galan 3T MRI systems (MRT-3020/MEXL-3020 models) due to potential ice formation in the magnet's venting system that could cause helium vessel rupture if a quench occurs.
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.
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Contact the company
📍Recalling firmCanon Medical System, USA, INC.2441 Michelle Dr · Tustin, CA 92780-7047
✎ GovInfoNow plain-language explainer
Canon Medical is recalling certain Vantage Galan 3T MRI systems (MRT-3020/MEXL-3020 models) because ice can form in the magnet's venting system. If a quench occurs, this might prevent helium from escaping, causing pressure buildup that could rupture the helium vessel and release gas into the MRI room. Read more at govinfonow.com/recall/50370-canon-medical-vantage-galan-3t-mri-recall-ice-risk-in.
“Canon Medical Vantage Galan 3T MRI Recall: Ice Risk in Superconducting Magnet.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50370-canon-medical-vantage-galan-3t-mri-recall-ice-risk-in. Based on FDA recall #Z-1017-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1017-2026%22&limit=1).
The FDA announced on Dec. 19, 2025, that Canon Medical System USA is recalling VANTAGE GALAN 3T MRI systems due to potential ice formation in the venting system. This defect could cause helium vessel rupture and gas release into scanning rooms if a quench occurs. The recall affects 34 units distributed nationwide.
How to tell if you have it
Brand: Canon Medical
Product: VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
UPC: 04987670102615
The hazard
According to the FDA, ice may form in the venting system of the superconducting magnet. If a quench occurs under these conditions, helium gas might not escape via designed paths, causing pressure buildup that could rupture the vessel and release gas into the MR scanning room.
Context
GovInfoNow's records show Canon Medical System USA has issued 26 other recalls since April 18, 2018. Recent similar product recalls include I.T.S. Volar Radius Plate PROlock II (Jan. 23, 2026), I.T.S. Hand Locking Plates System (Jan. 23, 2026), and I.T.S. GmbH FR.O.H. Calcaneus Repair System (Jan. 23, 2026).
How to tell if you have this one
Check for the model numbers MRT-3020 or MEXL-3020 with the specific serial numbers listed in the recall notice. The units were sold between 2013 and 2017.
Brand
Canon Medical
Product
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Identify if your MRI system has the model numbers MRT-3020 or MEXL-3020 with the specific serial numbers listed in the recall notice.
Contact Manufacturer
Reach out to Canon Medical System, USA, INC. to confirm if your unit is affected and get instructions for next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1017-2026 (December 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1017-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.