FDA DevicesClass II
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Published: January 21, 2026Recall ID: Z-1017-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Affected Products
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Additional Source Details
| Field | Value |
|---|---|
| City | Tustin |
| State | CA |
| Event id | 98112 |
| Address 1 | 2441 Michelle Dr |
| Code info | Model Number: MRT-3020/MEXL-3020 UDI-DI code: 04987670102615 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3020/4A MEXL-3020/5D 5DB2152002 30058153 (01)04987670102615(21)4AA2152001 MRT-3020/4A MEXL-3020/5D 5DC2262005 30075456 (01)04987670102615(21)4AB2262002 MRT-3020/4A MEXL-3020/5D 5DE2452007 30097122 (01)04987670102615(21)4AC2452003 MRT-3020/5A MEXL-3020/5D 5DB2172003 30047848 (01)04987670102615(21)5AA2172001 MRT-3020/6A MEXL-3020/7D 7DE2482014 30102813 (01)04987670102615(21)6AA2482002 MRT-3020/6A MEXL-3020/7D 7DE2472012 30108012 (01)04987670102615(21)6AA2472001 MRT-3020/7A MEXL-3020/7D 7DD2392008 30100563 (01)04987670102615(21)7AA2392001 MRT-3020/A4 MEXL-3020/D5 D5B2152013 30060527 (01)04987670102615(21)A4D2152004 MRT-3020/A4 MEXL-3020/D5 D5B2212019 30064817 (01)04987670102615(21)A4D2212006 MRT-3020/A4 MEXL-3020/D5 D5A2082005 30069306 (01)04987670102615(21)A4C2082002 MRT-3020/A4 MEXL-3020/D5 D5A2092007 30071480 (01)04987670102615(21)A4C2092003 MRT-3020/A4 MEXL-3020... [TRUNCATED] |
| Postal code | 92780-7047 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 34 systems |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20260113 |
Overview
- Recalling FirmCanon Medical System, USA, INC.
- StatusOngoing
- Risk LevelClass II
- DistributionU.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.