VesselNavigator application used with Philips Azurion (Azurion 7 Series) S ...



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.
Components:
Units Affected:    443
Recall Date:    Dec 23, 2019
Mfg:
Philips North America, LLC
Mfg Country:
United States
Recall ID:    84708
Product ID:    179087
Enforcement Date:    Feb 19, 2020
Last Published:    Mar 9, 2020

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Emert Number:    Z-1145-2020
Emert Status:    Announced