Canon Medical System, USA, INC. recalls Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiogr…

Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.

On 08/04/2026, an "URGENT: MEDICAL DEVICE CORRECTION" letter was sent via email informing customers that, It has been found there is a possibility that the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Indications that the screws have loosened are abnormal noises and sensor errors from the ceiling mounted C-arm. Customers are instructed to: 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. A representative of Canon Medical Systems USA will contact customers to schedule a time to check for the tightening and proper attachment of the fixing screws to correct this issue your system(s). For Questions - contact your service representative contact the InTouch team at intouchdispatch@us.medical.canon.

• FDA enforcement recordOfficial FDA database entry for Z-3014-2026
• FDA 510(k) clearance · K182415The device's official FDA premarket clearance record
• FDA 510(k) clearance · K203551The device's official FDA premarket clearance record
• FDA 510(k) clearance · K210900The 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.