FDA Enforcement
Class II
Ongoing
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Recall: Z-1178-2026
·
Reported February 4, 2026
Enforcement
- Recall Number
- Z-1178-2026
- Event ID
- 97970
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Canon Medical System, USA, INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 4, 2026
- Initiation Date
- December 19, 2025
- Classification Date
- January 27, 2026
- Address
- 2441 Michelle Dr, N/A, Tustin, CA, 92780-7047, United States
Description
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
Code Info
serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
Distribution
Worldwide distribution - US Nationwide and the country of Dominican Republic.
Quantity
3 units