Recall Z-1809-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Philips North America, LLC
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
| Date | Apr 29, 2020 (initiated Apr 3, 2020) |
| Status | Terminated |
| Reason | When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guidance, a warning message directs the user to move the L-arm stand back to the initial XperCT scan position. Although the software generates this message, it does not prevent the use of live guidance if the L-arm stand is not repositioned. Using live guidance with a mispositioned L-arm can result in the display of an incorrect overlay and needle path. |
| Root cause | Software design |
| Action | Philips Healthcare issued Urgent Medical Device Correction letter via Field Action 2020-IGTBST-003 issued on April 3, 2020. Letter states reason for recall, health risk an action to take: To avoid this hazardous situation, the users should: BY CUSTOMER/ USER " Use XperGuide live guidance with the L-arm positioned in the XperCT scan position. " Move the L-arm back to the initial XperCT scan position if the system displays the warning Live 3D roadmap not possible. Please move stand to the : [acquisition position] position. At any stage during needle guidance, the user can perform a verification |
| Quantity | 22 units (6 US and 16 OUS); Expanded 3units; Total: 25 |
| Distribution | Worldwide distribution. US states of FL, ID, IL, IN, MA, and OH, Canada, Australia, Austria, Belgium, Germany, and Netherlands New Zealand, South Africa, Switzerland, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181830 | Azurion R2.0 Philips Medical Systems Nederland B.V., Aug 2, 2018 |