Recall Z-1145-2020— Philips North America, LLC
Class II · Terminated
Class II FDA medical device recall by Philips North America, LLC, initiated 2019-12-23, terminated 2022-11-17. It names 3 FDA 510(k) clearances: K181830, K172822, K162148. 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: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction..
- Recalling firm
- Philips North America, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-23
- Terminated
- 2022-11-17
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.