Alphenix INFX-8000H, interventional fluoroscopic x-ray system
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 19, 2025 |
| Reported | February 04, 2026 |
| Recalling firm | Canon Medical System, USA, INC. |
| Country / region | United States CA |
Hazard
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
Affected products
- Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Related recalls
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