Canon Alphenix angiography system recalled over software error
What this means
Canon Medical Systems USA is recalling 31 Alphenix interventional angiography X-ray systems (REF INFX-8000V) sold in parts of the U.S. A software issue can cause an internal error if F-Store or image acquisition is performed while the clinical analysis function is in use. No injuries have been reported.
- Check whether your facility has an Alphenix system with REF INFX-8000V.
- Contact Canon Medical Systems USA for the recall notice and any interim steps for using the system.
- Ask Canon about the software fix before running F-Store or image acquisition with clinical analysis in use.
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-8000CZ-0289-2027 · 15 SYSTEMS
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000FZ-0290-2027 · 3 units
- ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000V (this page)Z-0291-2027 · 31 units
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0291-2027More Canon recalls
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