Canon Medical System, USA, INC. recalls ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
- Recalling company
- Canon Medical System, USA, INC.
- Product
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
- Reason
- Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 12, 2026
- Reported
- Nov 4, 2026
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, LA, MA, MI, MN, MS, NC, NV, OH, OR, TX.
- Status
- Ongoing
- Quantity
- 15 SYSTEMS
- Lot / codes
- DI-04987670100192
- Company location
- Tustin, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0289-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0289-2027 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.