Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
- Recalling company
- Canon Medical System, USA, INC.
- Product
- Alphenix INFX-8000C/B5
- Reason
- Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 26, 2026
- Reported
- Oct 14, 2026
- Distribution
- US Nationwide distribution in the state of ID.
- Status
- Ongoing
- Quantity
- 1 unit
- Lot / codes
- Serial no. B5F2532011/UDI: 4987670100192
- Company location
- Tustin, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0108-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0108-2027 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.