FDA Device recall Z-1809-2020
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluor…
- FDA Device
- Class II
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluor… by Philips North America, citing 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 guid….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1809-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-03 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | FL, ID, IL, IN, MA, OH |
Product
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
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.
Identifiers
| code_info | Software:Philips Azurion 2.0 Interventional Fluoroscopic X-ray system with Interventional Workspot 1.5 US Serial Nu…Software:Philips Azurion 2.0 Interventional Fluoroscopic X-ray system with Interventional Workspot 1.5 US Serial Numbers: 637, 200, 909, 1276, 1309, 987 Canada: 1016 ROW: 11169 1129 1143 971 1135 824 934 1089 1008 1165 1080 1019 1248 523 1172 Expanded Recall OUS: 1223, 1330, 703424 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1809-2020%22
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