VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 — Class II medical device recall Z-1018-2026
Ongoing recall by Canon Medical System, USA, INC., reported 2026-01-21, distributed nationwide. There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the
| Recall number | Z-1018-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2025-12-19 |
| Classified | 2026-01-13 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 22 systems |
| UPC / GTIN / UDI-DI | 04987670101649 |
| Model numbers | MRT-3010/MEXL-3010 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1018-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.