Canon Medical System, Usa, Inc.: Alphenix Interventional Angiography System Ref: Infx-8000c
Recall Summary Canon Medical System's ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM (model INFX-8000C) is being recalled due to a software problem that can cause internal errors when certain imaging functions are used simultaneously. The affected X-ray systems were distributed across the United States. Healthcare facilities that operate this equipment should contact Canon Medical System for instructions on addressing this issue.
- Recalling firm
- 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
- 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/def7e0e4-33b9-44c9-95c1-bb3010ece3b5