FDA Device recall Z-1018-2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 by Canon Medical System Usa, citing 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 no….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1018-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Canon Medical System Usa |
| Distribution | US |
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.
Identifiers
| code_info | Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code…Model Number: MRT-3010/MEXL-3010 UDI-DI code: 04987670101649 CMSC Model Number/Model Number/Serial Numbers/SID/UDI code: MRT-3010/A5 MEXL-3010/A5 A5D14X2031 30000041 MRT-3010/A5 MEXL-3010/A5 A5D13Y2025 30001708 MRT-3010/A5 MEXL-3010/A5 A5D13Y2026 30005894 MRT-3010/A5 MEXL-3010/A5 A5G1692039 30007620 (01)04987670101649(21)A5G1692039 MRT-3010/A5 MEXL-3010/A5.007 A5B11Y2006 30019175 MRT-3010/A7 MEXL-3010/S7 S7A1642006 30024266 (01)04987670101649(21)A7A1642001 MRT-3010/A5 MEXL-3010/A5 A5G1692038 30027318 (01)04987670101649(21)A5G1692038 MRT-3010/A5 MEXL-3010/A5 A5G1642036 30029482 (01)04987670101649(21)A5G1642036 MRT-3010/A5 MEXL-3010/A5.007 A5F1562034 30050314 MRT-3010/A5 MEXL-3010/A5 A5B11Z2007 303354 MRT-3010/A5 MEXL-3010/A5 A5C1252012 336719 MRT-3010/A5 MEXL-3010/A5 A5D1312019 350553 MRT-3010/A5 MEXL-3010/A5 A5B1192003 350579 MRT-3010/A5 MEXL-3010/A5 A5C12X2016 350918 MRT-3010/A5 MEXL-3010/A5 A5C12Y2017 351122 MRT-3010/A5 MEXL-3010/A5 A5C1212009 351387 MRT-3010/A5 MEXL-3010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2026%22
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