FDA-Device2026-01-21Class II
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, INC.
Hazard
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Sold states
U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.
Affected count
22 systems
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2026Don't want to check this manually?
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