FDA-Device2026-10-27Class IIPROCESSING DEFECT
Canon Alphenix angiography system recalled over software error risk
What this means
Canon Medical Systems USA is recalling three Alphenix interventional angiography (X-ray) systems, model INFX-8000F. 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.
- Contact your facility's biomedical engineering team to confirm whether your system is affected.
- Contact Canon Medical Systems USA for remedy instructions, since the notice does not list one.
The agency's original wording
Hazard
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.
Intended for
All ages (under 100 years)
Illnesses reported
None reported
Sold states
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.
Affected count
3 units
Manufactured in
2441 Michelle Dr, Tustin, California, United States
Products
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000F
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-8000F (this page)Z-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-0290-2027More Canon recalls
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