Alphenix Interventional Angiography System (INFX-8000F) Recall: Software Issue
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Alphenix Interventional Angiography System recalled?
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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Which lot codes, UPCs or models are affected?
DI-04987670100208/
- Agency record number
- Z-0290-2027
- Product
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
- Recalling firm
- Canon Medical System, USA, INC.
- Quantity
- 3 units
- 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.
- Recall started
- October 12, 2026
- Report date
- November 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)