Device product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Z-1178-2026
Product summary
- Event
- Event 97970
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1178-2026
Official wording
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
Code information: serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Distribution pattern: Worldwide distribution - US Nationwide and the country of Dominican Republic.
Derived failure modes
-
Unknown
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