Recall Z-0291-2027— Canon Medical System, USA, INC.

Name: FDA recall Z-0291-2027
Creator: U.S. Food and Drug Administration
Published: 2026-10-12

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2026-10-12. It names 2 FDA 510(k) clearances: K233107, K203551. Product: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V. Reason: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2026-10-12
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation·cleared 2024-08-30
K203551 — Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation·cleared 2020-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.