Canon recalls

Canon Medical Systems is recalling 15 Alphenix interventional angiography X-ray systems (model INFX-8000C). A software issue can cause an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use. The systems were distributed to hospitals and facilities in 18 states.

Moderate·FDA·Oct 27, 20263 products

Bolts that secure the longitudinal movement mechanism on the Canon Medical Alphenix INFX-8000C/B5 imaging system may loosen over time. This can cause the patient tabletop to shift unexpectedly, leading to misalignment during imaging procedures and motion errors.

Moderate·FDA·Oct 14, 2026

Fixing screws on the ceiling movement gear of the suspended arm in Canon Medical Alphenix interventional X-ray systems may become loose over time. This could potentially cause the arm to shift during use. Ten systems are affected across eight U.S. states.

Moderate·FDA·Sep 2, 2026

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.

Moderate·FDA·Feb 4, 20264 products

Canon is recalling 2 Vantage 3T MRI models, with 56 systems affected in total. Ice can form in the venting system of the superconducting magnet, so if a quench occurs, helium gas may not escape through its vent paths, and pressure in the helium vessel can rise. This could eventually rupture the vessel and release helium gas into the MR scanning room. No injuries have been reported.

Moderate·FDA·Jan 21, 20262 products