Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 Recalled by Canon Medical System, USA, INC. Due to There is a potential for formation of ice...

Date: December 19, 2025
Company: Canon Medical System, USA, INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Canon Medical System, USA, INC. directly.

Affected Products

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

Quantity: 22 systems

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Canon Medical System, USA, INC.

Canon Medical System, USA, INC. has 49 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report