FDA-Device2020-02-19Class II
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.
Philips North America, LLC
Hazard
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
Sold states
Worldwide Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Uruguay.
Affected count
443
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2020Don't want to check this manually?
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