VesselNavigator application used with Philips Azurion — Class II medical device recall Z-1145-2020

Terminated recall by Philips North America, LLC, reported 2020-02-19, distributed nationwide. Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator appl

Recall number	`Z-1145-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Philips North America, LLC, Andover, MA, United States
Recall initiated	2019-12-23
Classified	2020-02-10
Reported by FDA	2020-02-19
Terminated	2022-11-17
Distributed	Nationwide (US)
Countries outside the US	AR, AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, EG, ES, FR, GB, GR, HR, ID, IE, IL, IN, IT, JO, JP, KR, LV, MX, NL, NO, NZ, OM, PH, PK, PL, PT, RS, SA, SG, TH, TR, TW, UY, ZA
Quantity	443
Reason classes	software

Product

VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

Reason for recall

Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1145-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.