FDADecember 23, 2019device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
What to do
FDA enforcement status: Terminated
Brands named
philips north americaphilipsphilips north
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCPetzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
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