Alphenix INFX-8000C, interventional fluoroscopic x-ray system
Recall
- Recall Number
- Z-1176-2026
- Event Number
- 97970
- Firm
- Canon Medical System, USA, INC.
- FEI Number
- 2020563
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- December 19, 2025
- Posted
- January 27, 2026
- Address
- 2441 Michelle Dr, Tustin, CA, 92780-7047
Description
Alphenix INFX-8000C, interventional fluoroscopic x-ray system
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 [email protected]."
Worldwide distribution - US Nationwide and the country of Dominican Republic.
172 units