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Lower risk Medical device recall · FDA · Published January 29, 2024

Canon Medical Vantage Elan MRI System Recall: Incorrect Safety Settings May Cause

Canon Medical recalls Vantage Elan MRI systems (Model MRT-2020) due to potential incorrect safety settings that may cause discomfort for patients with MR conditional devices during scans.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1249-2024Medical deviceCanon Medical ›
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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 Vantage Elan MRI systems (Model MRT-2020) because some safety settings might be incorrect, which could cause discomfort for patients with MR conditional devices during scans. This recall does not involve immediate safety risks but requires attention to ensure patient comfort. Read more at govinfonow.com/recall/56232-canon-medical-vantage-elan-mri-system-recall-incorrect-safety-settings.

Source Summary by GovInfoNow · govinfonow.com/recall/56232-canon-medical-vantage-elan-mri-system-recall-incorrect-safety-settings · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1249-2024

Cite this page

“Canon Medical Vantage Elan MRI System Recall: Incorrect Safety Settings May Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56232-canon-medical-vantage-elan-mri-system-recall-incorrect-safety-settings. Based on FDA recall #Z-1249-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2024%22&limit=1).

The FDA announced on Jan. 29, 2024, that Canon Medical System, USA, INC. is recalling one Vantage Elan MRI system (Model MRT-2020) because displayed gradient values may be incorrect. This error could cause discomfort for patients with MR conditional devices during scans.

How to tell if you have it

  • Brand: Canon Medical
  • Product: Vantage Elan MRI system
  • Model: MRT-2020
  • UDI-DI: 04987670101632
  • Serial Number: S1F2052753

The hazard

The FDA said the maximum Spatial Field Gradient values displayed in the operation window and described in the safety manual may be lower than correct. This discrepancy may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

Context

GovInfoNow's records show Canon Medical System, USA, INC. has issued 26 other recalls since April 18, 2018. Recent brand recalls include a loose fixing screws risk for Alphenix X-ray Systems on Aug. 4, 2026, and an ice risk in venting systems for Vantage Titan 3T MRI Systems on Dec. 19, 2025. Other recent recalls of similar products include Philips Ingenia Ambition S MRE Scanner Recall (April 14, 2026) and Philips Achieva 1.5T MRE System Recall (April 14, 2026).

How to tell if you have this one

Check for the Vantage Elan MRI system with Model MRT-2020. The serial number is S1F2052753 and the UDI-DI is 04987670101632.

  • Brand
    Canon Medical
  • Category
    Medical device
FDA recall event · 3 products

All 3 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
    Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and the country of DO.
Recall numberProduct, codes & lotsQuantity
Z-1248-2024MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550; UDI-DI: 04987670103360, 04987670104831. Serial Numbers: S2A1962005, S6B2312016, S2B2042009, S6B2262010, S4B2062020, S5B2292037, S2B2052011, S2B20Z2015, S6A20Z2001, SFA2372005, S5B2272031, S8B22X2013, S5B2122013, S8B2272009, S5B2172019, S2A1942004, S2C2252023, S2A18Z2001, S2A18Z2002, S5B22Z2043, S2C2192020, S2A18Z2003, S2B2052010, S5B2352047, S5B2272030, S6B2262011, S5B2182021, S6B2222006, PDA22Y2003, S6B2362019, S5A2062007, S6B2252009, S5A1982001, S2C2142017, POA2292008, S1A1922022, S2B2072012, S2B2072013, S4A1992013, S3A19Z2013, S3A1982009, S1B2042051, S5B2242027, S5A19Z2003, S6B2222005, S6B22Z2014, S5A20Z2009, S5B2142015, S5A20Z2010, S7B22Y2047, S5B2172018, S1B2062057, S5A2092008, S6B2112002, S2C2212022, S2C2272025, S6B2182004, POA2282007, S1B2092067, S2C2132016, S5B2282034, S5B2272029, S8B22X2012, S6B2322018, S5B2292038, S5B2282033, S6B22Z2015, S5B2282032, S1C2152071, SFA22Z2002, S2C2162019, S2B2072014, S2C2162018, S1C2142070, S6B2292013, S5B2132014, S2C21Y2021, POA21X2002, S6B2252007, PDA21Y2001, S1C2262081, S5B22Z2042, S7B2122011, S8B2212007, S6B2322017, S5B2292036, POA2182001, S8B2272010, POA2212003, POA22X2010, POA2272006, POA2262005, S5B2292035, POA2252004, S1C2242080, PDA2312004, S6B2252008, S2C2252024, POA2342011, S6B2272012, POA2292009, S8B2312015, S8B22Y2014, PDA2282002, S8B2292011, SFA2332003, SGA2362032, PDA2342005, S6B2382021, S5B22Z2041, S5B22Y2040, S5B2162017, S1C2342084, S1C2352085, SAB2382012, SGA22Z2011, SGA2372034, SHA2382011118
Z-1249-2024MRI system: Vantage Elan, Model: MRT-2020; UDI-DI: 04987670101632. Serial Number: S1F20527531
Z-1250-2024Vantage Titan, Model: MRT-1504; UDI-DI: 04987670102400. Serial Numbers: U4B15Y2102, U5B15Z2001, U4B1492080, U4B1582100, U4B1582099, U4B1522091, U4B1512089, U4B1432067, U4B1522093, U4B1452073, U4B1442069, U4B1442068, U4B1642106, U4B1432066, U4B15X2101, U4B14Y2083, U4B1452071, U4B1512087, U4B1652107, U4B1552097, U4B1482078, U4B1512090, U4B1552098, U4B1442070, U4B14Y2082, U4B1482076, U4B14Z2085, U4B14Z2086, U4B1512088, U4B1612103, U4B1472075, U4B1422065, U4B1462074, U4B14Y2084, U4B1632105, U4B1452072, U4B1492081, U4B1482079, U4B1612104, U4B148207740
Based on the official FDA remedy

What to do — step by step

  1. Check System Settings

    Verify the maximum Spatial Field Gradient (SFG) values in the system's "System Information" window and safety manual to ensure they match the correct values.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 41 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide - US Nationwide distribution including in the states of MD, IL, WV, CA, AZ, PR, CO, GA, PA, WA, UT, OK, KY, IA, IN, TN, CT, WI, OH, AL, MT, NM, TX, MO, MN, OR, ID, WY, NV, AR, FL, SD, MI, NY, NJ, KS, LA, NH, VT, MS, SC, ME and…” 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, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Jan 29, 202412. FDA classified it Class II: Mar 4, 202423. Published in FDA’s Enforcement Report: Mar 13, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the MRI system?

No, the recall does not require stopping use. However, checking the system settings for correct SFG values is recommended to ensure patient comfort.

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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-1249-2024 (January 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1249-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA