Recall Z-1145-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
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 interventio
| Date | Feb 10, 2020 (initiated Dec 23, 2019) |
| Status | Terminated |
| Reason | Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction. |
| Root cause | Software design |
| Action | On 12/23/2019, the firm sent medical device correction letters to affected customers via certified mail. The firm will be contacting customers with affected systems. The firm will be implementing software updates in all affected systems to correct the issue which was made available by the end of December 2019. The user was asked to do the following: -Please suspend the use of Digital Subtraction Angiography images for the verification of the registration during the Live Guidance step. -Please ensure that all staff working with the VesselNavigator application are informed of the recall. If y |
| Quantity | 443 |
| Distribution | 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, Netherland |
| FDA record | Open on fda.gov |