VANTAGE GALAN 3T
Medical device recall Z-1017-2026. Published in FDA’s Enforcement Report on Jan 21, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 21, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 19 states named
- 34 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
34 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005…
Every code shown here, 1,993 characters
Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020/D5 D5E24X2043 30072643 (01)04987670102615(21)A4F24X2010 MRT-3020/A4 MEXL-3020/D5 D5B2192016 30085151 (01)04987670102615(21)A4D2192005 MRT-3020/A4 MEXL-3020/D5 D5C2262022 30098384 (01)04987670102615(21)A4E2262008 MRT-3020/A4 MEXL-3020/D5 D5C2262021 30100803 (01)04987670102615(21)A4E2262007 MRT-3020/A4 MEXL-3020/D5 D5E2492042 30109383 (01)04987670102615(21)A4F2492009 MRT-3020/A5 MEXL-3020/S5 S5B18X2046 30007763 (01)04987670102615(21)A5B18X2011 MRT-3020/A5 MEXL-3020/S5 S5A17X2033 30031740 (01)04987670102615(21)A5A17X2008 MRT-3020/A5 MEXL-3020/S5 S5B17X2034 30034832 (01)04987670102615(21)A5B1882010 MRT-3020/A5 MEXL-3020/S5 S5A1732019 30036503 (01)04987670102615(21)A5A1732004 MRT-3020/A5 MEXL-3020/S5 S5A1742021 30040917 (01)04987670102615(21)A5A1742005 MRT-3020/A5 MEXL-3020/S5 S5C1972054 30041962 (01)04987670102615(21)A5C1972014 MRT-3020/A5 MEXL-3020/S5 S5A1732018 30042870 (01)04987670102615(21)A5A1732003 MRT-3020/A5 MEXL-3020/S5 S5B1842043 30043510 (01)04987670102615(21)A5B18X2012…
FDA’s list runs to 2,972 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
19 states and territories.
Every one of them
- California
- Colorado
- Florida
- Iowa
- Illinois
- Indiana
- Kansas
- Maryland
- Missouri
- Montana
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Puerto Rico
- Texas
- Virginia
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 19, 2025.
- FDA classified it on Jan 13, 2026.
- FDA’s Enforcement Report published it on Jan 21, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Canon Medical System, USA, INC., of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,972 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.