Canon Medical System, USA, INC. recalls Alphenix INFX-8000H
- Recalling company
- Canon Medical System, USA, INC.
- Product
- 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
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 19, 2025
- Reported
- Feb 4, 2026
- Distribution
- Worldwide distribution - US Nationwide and the country of Dominican Republic.
- Status
- Ongoing
- Quantity
- 3 units
- Lot / codes
- serial numbers: D2A1672385, A2A20Z2165, B2A1692426.
- Company location
- Tustin, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1178-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1178-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.