Alphenix INFX-8000H recall (Canon Medical System, USA, INC.)
Medical deviceClass IIOngoing
Summary: Canon Medical System, USA, INC. is recalling Alphenix INFX-8000H, interventional fluoroscopic x-ray system. 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.
What is being recalled
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Why
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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the country of Dominican Republic.
How to tell if yours is affected
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1178-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 19, 2025 |
| Reported | February 4, 2026 |
| Company | Canon Medical System, USA, INC. |
| Company location | Tustin, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3 units |
More recalls from Canon Medical System, USA, INC. · all medical device recalls · recalls from December 2025