Canon Medical System, Usa, Inc.: Interventional Fluoroscopic X-ray System
Recall Summary Canon Medical System's ALPHENIX interventional angiography X-ray systems (model INFX-8000V) are being recalled due to a software issue that can cause internal errors when certain imaging functions are used simultaneously. The recall affects systems distributed nationwide across multiple states. This is classified as a Class II recall, meaning the device could cause serious health consequences or device failure.
- 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
- FDA-DEVICES
- Recall date
- 2026-10-12
- Status
- Open, Classified
- 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 FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/08fd2bd8-5b88-4887-9be3-c453c71a89d6