Company: Philips North America, LLC
Date of Enforcement Report: 5/7/2020
Class II
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
Recall Number: Z-1809-2020
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.
RECALLING FIRM/MANUFACTURER
Philips North America, LLC on 4/3/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 units (6 US and 16 OUS)
DISTRIBUTION
U.S. Nationwide and International