Canon Alphenix angiography system recalled for software error risk
What this means
Canon Medical Systems is recalling 15 Alphenix interventional angiography X-ray systems (model INFX-8000C). A software issue can cause an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use. The systems were distributed to hospitals and facilities in 18 states.
- Check with your hospital or facility to confirm whether it operates an affected Alphenix system.
- Follow the facility's guidance on use of the system while the software issue is addressed.
- Contact Canon Medical Systems USA with questions about the recall.
The agency's original wording
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.
Products in this recall · 3
The agency lists each product in this recall separately. Check every one you might have.
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000C (this page)Z-0289-2027 · 15 SYSTEMS
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000FZ-0290-2027 · 3 units
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000VZ-0291-2027 · 31 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2027More Canon recalls
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