Canon Vantage Titan 3T MRI System Recall: Fire Risk from Flame Retardancy Issue
Canon recalls Vantage Titan 3T MRI systems with serial numbers starting with A5 or S7 for potential fire risk due to inadequate flame retardancy. Affected units may produce smoke or fire during use.
Use caution until it’s fixed
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Contact the company
What happened, in plain English
Canon is recalling specific models of their Vantage Titan 3T MRI systems because a component fails to meet flame retardancy standards, which could cause smoke or fire. This poses a fire hazard during normal medical imaging use. Read more at govinfonow.com/recall/62498-canon-vantage-titan-3t-mri-system-recall-fire-risk-from.
Source Summary by GovInfoNow · govinfonow.com/recall/62498-canon-vantage-titan-3t-mri-system-recall-fire-risk-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2046-2021
Cite this page
“Canon Vantage Titan 3T MRI System Recall: Fire Risk from Flame Retardancy Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62498-canon-vantage-titan-3t-mri-system-recall-fire-risk-from. Based on FDA recall #Z-2046-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2021%22&limit=1).
Why it’s dangerous
The MRI system contains a component that does not meet required flame retardancy ratings. This could lead to smoke or fire if the system is used as a diagnostic imaging device, especially during prolonged operations or in environments where heat buildup is possible.
Who’s affected
Medical facilities using the Canon Vantage Titan 3T MRI system with the listed serial numbers are affected. Patients and staff at these facilities face the highest risk due to the potential fire hazard during imaging procedures.
How to tell if you have this one
Check the serial number on your Canon Vantage Titan 3T MRI system. Affected units have serial numbers starting with A5 or S7, such as A5B1182002 or S7A1642006. The system is used for diagnostic imaging that produces cross-sectional images of the head or body.
- Brand
Canon- Category
Medical device
All 4 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
US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2044-2021 | Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.; Affected serial numbers: U4A12Z2020, S4D1132069, S4A1032017, U4B1492081, U4B1582100, S4A1072035, A4A1222019, S4D1172090, U4A1312024, S4A1072034, S4A1082040, A4A11Z2011, U4A1282003, U4B1442070, U4A1352035, U4B1552097, U4A12X2010, S4C1112065, S4C1112064, S3A0922024, S4E1192094, A4A11Z2009, S3A0972032, S4A09Y2002, S4A09Z2006, U4A1382047, S4A1062031, S3A0972030, U4A12X2011, S4C1112061, U4A13X2054, A4A1222015, U4B1642106, A4A1222017, S4A10X2047, S4A09Z2007, U4B1522092, A4A11X2004, S4D1132074, U4A1312023, S4A1052025, S3A0982035, S3A08Y2014, U4A1312022, S4B10Y2051, U4A1352036, U4A1372046, S4D1142076, U4A1292007, U4B1632105, S4B10Y2052, U4A1352037, U4A12Z2018, U4A1312021, U4B1482077, A4A11X2002, U4B14Y2082, U4A13X2051, S4B10Y2050, A4A1252024, U4B1532094, U4B1652107, S3A0922023, S4B10Z2059, S4A09Z2008, U4A1382049, S4D1142078, L3A08Z2002, U4A12Z2014, S3A0822001, A4A11Z2010, S3A0852004, S3A0892009, A4A11X2003, S3A0882007, S4D1132073, U4A1362039, U4B1462074, U4B1522091, U4A1342033, U4A1342034, U4A12X2009, U4A1412059, U4A1412063, U4A1282004, U4A1352038, U4A12Y2013, U4B14Z2086, S4A1022016, S3A0942027, S4D1162084, U4A1292006, S4A1042023, U4B1512089, A4A11X2001, U4A1342029, S4E1192095, U4A1362041, U4A12Y2012, S4A1032018, S3A0952029, U4A1382050, A4A1242021, S4A1092046, A4A1252023, S3A0982033, U4B15Y2102, S4A09Y2004, S4D1132071, S4D1142075, U4A13Y2056, S4A10X2048, S4A1092043, U4B1522093, A4A1232020, A4A11Y2007, S4D1162087, S4A1012010, U4A1412061, S3A1062029, S4D1172088, S3A0872005, A4A1212013, U4B1482076, S4C1112063, U4B1552098, S4D1152080, S4A1042021, S4B10Z2057, U4A1292008, A4A1222016, U4B1432067, U4B1492080, U4A1362042, S4A1092045, S4A1062028, U4B1452071, A4A1242022, A4A1262025, S4A1082036, S4C1112060, S4D1152081, U4A12Z2019, U4B1512090, S4A1042024, U4A13X2055, S4D1132072, A4A11X2005, U4B15X2101, U4B1482079, S4A1072032, U4A12Z2017, S4A1022013, U4B1612103, S4D1132070, S3A0872006, U4A1322025, U4A1382048, S3A0892008, U4B1612104, S4E1182093, U4A13X2052, U4B1542095, S4A1042020, S4A1082037, U4A12Z2015, S3A0922025, S3A0982034, U4B1452072, S4A09Z2005, U4B1452073, U4B1582099, S4A1022015, U4B14Y2084, S3A08X2010, S4D1162085, S3A08Y2013, S4A1092044, S4B10Y2055, A4A1222018, A4A1222014, S4D1172089, U4B1432066, U4B1442069, U4A13Z2057, L3A08Z2001, S3A09X2041, A4A11Y2008, S4A1062030, S3A08Y2012, U4B1472075, S3A0992038, S3A0952028, S3A09X2040, U4A1362043, S4A1042022, U4B1512087, S4D1162086, U4A1342031, U4A1342032, U4A1362040, S4B10Y2053, S4E1182092, S4C1112066, S4A1082042, U4A12Z2016, S4A1012009, S4A1082038, S3A0972031, S4B10Z2056, U4A1282005, U4B1512088, S4A1052026, S4A1012011, U4B14Z2085, U4A1412060, U4A1332028, U4A13X2053, U4B1442068, U4A1362045, U4B14Y2083, U4B1482078, U4B1422065, S3A0932026, U4A1362044, S4A1082039, U4B1542096, U4A1412062, S4A1012012, U4A1282002, U4A1342030, S4A09Y2003 | — |
| Z-2045-2021 | Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.; Affected Serial Numbers: S3C18Y2032, S3C1892029, S3C1912035, S3C2042045, S3A16Z2007, S3B1782012, S3A1692003, S3C1912036, S3C2012043, S3C1882028, S3C19Z2042, S3B17Y2016, S3C1842019, S3C1912034, S3C18Z2033, S3C2012044, S3C2082046, S3B1762010, S3B1762009, S3C1872025, S3C1932039, S3C1812017, S3C19Z2041, S3C1832018, S3B17X2015, S3A16Z2006, S3C1852021, S3C18X2030, S3C1932040, S3C1922038, S3A16Y2004, S3B1782013, S3C1842020, S3C1882026, S3C1912037, S3B1772011, S3A16Z2005, S3C1882027, S3B1782014 | — |
| Z-2046-2021 | Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.; Affected Serial Numbers: A5B1182002, A5B11Y2005, A5D14X2032, A5A1082001, A5C12Y2017, A5D13Y2025, A5C1412028, S7A1642006, A5D13Y2026, A5F1562034, A5B1192004, A5C1222010, A5C1212009, A5C12X2016, A5G1692038, A5G1642036, A5C1232011, A5C1252012, A5D13Z2027, A5D1492030, A5C1262013, A5E1522033, A5G1692039, A5D14X2031, A5B1192003, A5B11Y2006, A5D1312019, A5G1652037, A5D1362021, A5C1292015, A5D13X2024, A5C1422029, A5D1322020, A5B11Z2007, A5C1212008, A5C12Z2018, A5D1372022 | — |
| Z-2047-2021 | Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.; Affected Serial Numbers: D5A2082005, S7B1992017, S5C1912050, S5A1662001, D5A2092007, S5B17X2034, S5B18X2046, S5A17X2033, S5A1742021, D5A2062003, S5C18Y2048, S5A1732019, S5A1732018, S5A17Y2035, S7B1892004, S5B1842043, S7B1962013, S5C1972054 | — |
What to do — step by step
Check Serial Number
Identify the serial number on your Canon Vantage Titan 3T MRI system to confirm if it is affected.
Contact Canon
Reach out to Canon Medical System, USA, INC. for further instructions on the recall process.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 44 states.
FDA distribution: “US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2046-2021 (May 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2046-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.