FDA Medical Device Recalls (openFDA)
Canon Medical System, USA, INC.: Vantage Titan, Model: MRT-1504
- Recall number
- Z-1250-2024
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- Vantage Titan, Model: MRT-1504
- Status
- Open, Classified
- Initiated
- 2024-01-29
- Posted
- 2024-03-04
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Component change control
- Action
- 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.
- Quantity
- 40
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K122613"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28