Z-1178-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Reason for Recall
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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Code Information
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.