Canon Medical System, USA, INC.: Device Recall

Recall #Z-0327-2026 · 10/16/2025

Class II: Risk

Recall Details

Recall Number: Z-0327-2026
Classification: Class II
Product Type: Device
Recalling Firm: Canon Medical System, USA, INC.
Status: Ongoing
Date Initiated: 10/16/2025
Location: Tustin, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Reason for Recall

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

Product Description

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

Distribution Pattern

US distribution to Ohio and Nevada

Other Recalls by Canon Medical System, USA, INC.

Class II: Risk 12/19/2025

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.
Class II: Risk 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II: Risk 12/19/2025

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.
Class II: Risk 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II: Risk 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed

View all recalls by Canon Medical System, USA, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.