TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan recallZ-1250-2024 · Canon Medical System, USA, INC. · initiated Jan 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
FDA root cause category: Component change control
What the company is doing
On 01/29/24, correction notices were emailed to customers who were informed the following: The parts required to address the issue are expected to be available no earlier than February 2024. Until the countermeasure is performed, please use the values shown in the table shown in the correction notice. Share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. If you have any questions regarding this letter please contact Regulatory Affairs at 800-421-1968 or your Canon service representative at 800-521-1968.
Recall details
- Recall number
- Z-1250-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 29, 2024
- Posted by the FDA
- Mar 4, 2024
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 40
- Product code
- LNH
- FDA submissions
- K122613
- 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.
Product description
Vantage Titan, Model: MRT-1504
Code information (models, lots, serial numbers)
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, U4B1482077
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan MRT-1504Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93874).
- Z-1248-2024 · Open, ClassifiedMRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550
- Z-1249-2024 · Open, ClassifiedMRI system: Vantage Elan, Model: MRT-2020
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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