Home / Recalls / Medical Devices
Philips North America, LLC recalls Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system
Recalled May 6, 2020 · FDA recall Z-1809-2020 · Philips North America
Hazard
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. · FDA Class II
Units
22 units (6 US and 16 OUS); Expanded 3units; Total: 25
Sold at
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
Description
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.
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
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →