Canon Medical System, Usa, Inc.: Alphenix Interventional Angiography System Ref: Infx-8000v
Plain-English Summary Canon Medical Systems is recalling the ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM (model INFX-8000V) due to a software issue that can cause internal errors when certain imaging functions are used simultaneously. The system is used in medical facilities across the United States to perform X-ray guided interventional procedures. This is classified as a Class II recall, meaning the problem could potentially cause serious patient harm or temporary health consequences.
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-10-12
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/e93953c0-60d6-4518-8f3b-293373b0deb4