Canon Medical System, USA, INC.: Device Recall

Recall Details

Recall Number

Z-1017-2026

Classification

Class II

Product Type

Device

Recalling Firm

Canon Medical System, USA, INC.

Status

Ongoing

Date Initiated

12/19/2025

Location

Tustin, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

34 systems

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.

Product Description

VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

Distribution Pattern

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.

Other Recalls by Canon Medical System, USA, INC.

• 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
• 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. →