FDA recall Z-1017-2026

Product

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2025-12-19

Report date

2026-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2026