Canon Medical System, Usa, Inc.: Alphenix Interventional Angiography System Ref: Infx-8000f
Canon Medical ALPHENIX System Recall Summary Canon Medical's ALPHENIX interventional angiography system (model INFX-8000F) is being recalled due to a software issue that may cause internal errors when certain imaging functions are used simultaneously. The recall affects medical facilities nationwide that received this X-ray imaging equipment.
- Recalling firm
- Canon Medical System, USA, INC.
- Product
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
- 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/6ba60528-b821-40d3-bc87-8dc79cd3b246