# FDA recall Z-1018-2026

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2025-12-19.

## 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.

## 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

- **Recall number:** Z-1018-2026
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2026

## Citation

> AI Analytics. FDA recall Z-1018-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1018-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*