FDA-Device2024-03-13Class II
Vantage Titan, Model: MRT-1504
Canon Medical System, USA, INC.
Hazard
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.
Sold states
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.
Affected count
40
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
Vantage Titan, Model: MRT-1504
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2024Don't want to check this manually?
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