Canon

Fixing screws on the ceiling movement gear of Canon Medical Alphenix INFX-8000V interventional X-ray systems may loosen over time. This can prevent the ceiling arm from moving side-to-side, cause unusual noises from the suspension system, or trigger sensor errors on the equipment.

Fixing screws on the ceiling-mounted arm of certain Canon Medical Alphenix X-ray systems may become loose. This can prevent the arm from moving side to side, cause unusual noise, or trigger error messages. Three units worldwide are affected.

Fixing screws on the ceiling movement gear in Canon Medical's Alphenix INFX-8000F X-ray systems may become loose over time. This can prevent the ceiling arm from moving side to side, cause unusual noises, or trigger sensor errors during procedures.

Fixing screws in the ceiling-mounted arm of Canon Medical's Alphenix INFX-8000C interventional X-ray systems may become loose. This can cause the ceiling arm to stop moving sideways, create unusual noises, or trigger sensor errors during use.

Ice can form in the venting system of Canon Medical VANTAGE TITAN 3T MRI machines (models MRT-3010/MEXL-3010). If the system undergoes a quench event while ice is present, helium gas may not escape properly and pressure inside the helium vessel could build up and rupture, releasing helium gas into the scanning room.

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.

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.