Z-1809-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- February 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units (6 US and 16 OUS); Expanded 3units; Total: 25
Product Description
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 for Recall
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.
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
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