Canon Medical System, USA, INC. recalls Alphenix INFX-8000H

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

Canon Medical Systems USA issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2025 via letter. The notice explained the issue, risk to health, and requested the following: "Request to customers: Should the suspended device make an abnormal noise, or a sensor error is displayed before the corrective action is implemented on your system, please stop using the device and call your local Canon Service Team. Additionally, it is strongly requested that you share the contents of this letter with all users as well as clinical engineering or biomedical group at your facility. If you have any questions regarding this matter, please contact your service representative or contact our InTouch team at intouchdispatch@us.medical.canon."

• FDA enforcement recordOfficial FDA database entry for Z-1178-2026
• FDA 510(k) clearance · K182546The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Canon Medical System, USA, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.