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.

Code information: 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

Distribution pattern: 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