Recall Z-1018-2026— Canon Medical System, USA, INC.

Name: FDA recall Z-1018-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2025-12-19. It names one FDA 510(k) clearance: K191128. Product: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K191128 — Vantage Titan 3T, MRT-3010, V2.5Canon Medical Systems Corporation·cleared 2019-06-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.