FDA recall, , Moderate risk
Canon Medical System Alphenix Interventional Angiography Systems
The Alphenix interventional angiography system may experience an internal error due to a software issue.
Summary by Recall Canary from the FDA notice
What happened
Canon Medical System, USA, INC., of Tustin, California, is voluntarily recalling the Alphenix Interventional Angiography System, models INFX-8000C, INFX-8000F, and INFX-8000V, due to a software issue. The X-ray interventional system may experience an internal error if F-Store or imagine acquisition is performed while clinical analysis function is use. The recall was initiated on October 12, 2026, and added to the FDA's Enforcement Report on October 27, 2026.
The recalled systems were distributed nationwide in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oregon, and Texas. Customers were notified by email.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Compare these details with yours, then check the recall notice to see which units are recalled.
Alphenix Interventional Angiography System REF: INFX-8000C
Alphenix Interventional Angiography System REF: INFX-8000F
Alphenix Interventional Angiography System REF: INFX-8000V
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
US Nationwide distribution in the states of Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, Ohio, Oregon, Texas.
- Recalled by
- Canon Medical System, USA, INC.Tustin, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 99889
- Recall numbers
- Z-0289-2027 to Z-0291-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
All recalls from Canon Medical System, USA, INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Canon Medical System, USA, INC. began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
