Z-0289-2027

Alphenix Interventional Angiography System Ref: Infx-8000C

Name: Z-0289-2027 Alphenix Interventional Angiography System Ref: Infx-8000C
Creator: Canon Medical System, USA, INC.
Published: 2026-10-12
License: https://open.fda.gov/license/

Canon Medical System, USA, INC. / initiated 2026-10-12 / Open, Classified

FDA source

Recall record

Recall number: Z-0289-2027
Status: Open, Classified
Initiated: 2026-10-12
Posted: 2026-10-27
Recalling firm: Canon Medical System, USA, INC.
Product: Alphenix Interventional Angiography System Ref: Infx-8000C
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
FDA root cause: Software design
Action: On October 12, 2026, Canon Medical Systems USA, Inc. issued a Urgent: Medical Device Correction to affected consignees. Canon provided the following to consignees: 1. A representative of Canon Medical Systems USA will contact you to schedule a time to conduct installation of modified software to prevent internal errors from occuring if F-STORE or image acquisition is performed while CAAS clinical analysis function is used. 2. If you have any questions regarding this matter, please contact your service representative or contact our InTouch team at (800) 521-1968 or by email [email protected]. 3. In order to comply with the FDA record keeping requirement, Canon respectfully requests that the attached form be completed and returned via email to [email protected]
Quantity in commerce: 15 SYSTEMS
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.
Product codes and lots: DI-04987670100192

Product code OWB

K210900Class IIAlphenix, INFX-8000C/B, INFX-8000C/S, V9.2Canon Medical Systems Corporation / cleared 2021-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-21, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)