FDA Medical Device · Z-0290-2027

ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F

Class II · Ongoing

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.

Affected lots / codes — check yours against thisDI-04987670100208/

Recalling firm: Canon Medical System, USA, INC., Tustin, CA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
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 initiated: October 12, 2026
Classified: October 27, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0290-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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