FDA-Device2026-01-21Class IIPROCESSING DEFECT
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
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.
Intended for
All ages
Illnesses reported
None reported
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
34 systems
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2026Want us to check the next one for you?
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