Canon Medical System, USA, INC. device recall (Cls II)

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 — Reason: 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. — Status: Ongoing