Recall Z-1179-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Canon Medical System, USA, INC.
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
| Date | Jan 27, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Process design |
| Action | 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 facil |
| Quantity | 332 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Dominican Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233107 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 Canon Medical Systems Corporation, Aug 30, 2024 |