Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

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 [email protected].