Canon Medical System, USA, INC.: Device Recall

Recall Details

Recall Number

Z-1178-2026

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

3 units

Reason for Recall

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

Product Description

Alphenix INFX-8000H, interventional fluoroscopic x-ray system

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Dominican Republic.

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. →