Class 2 Device Recall Azurion R2.0

• Date Initiated by Firm: April 03, 2020
• Date Posted: April 29, 2020
• Recall Status: Terminated on February 01, 2023
• Recall Number: Z-1809-2020
• Recall Event ID: 85399
• 510(K)Number: K181830
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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
• 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
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Roland Telson; 978-659-3000
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Philips Healthcare issued Urgent Medical Device Correction letter via Field Action 2020-IGTBST-003 issued on April 3, 2020. Letter states reason for recall, health risk an action to take: To avoid this hazardous situation, the users should: BY CUSTOMER/ USER " Use XperGuide live guidance with the L-arm positioned in the XperCT scan position. " Move the L-arm back to the initial XperCT scan position if the system displays the warning Live 3D roadmap not possible. Please move stand to the : [acquisition position] position . At any stage during needle guidance, the user can perform a verification run to verify if the needle position is correct. Please ensure that all staff working with the XperGuide application are informed of the content of this letter and place a copy of this letter as an addendum to the Instructions for Use. Questions contact your local Philips representative. Technical Support Line: 1-800-722-9377. Philips will resolve the problem for all affected systems by installing a new Interventional Workspot software release. This action will start in April 2020. Expanded Recall 12-22-20: The two systems for the Netherland have already been corrected through the implementation of software update. For the system in Germany, the Customer has been notified through the Field Safety Notice.
• Quantity in Commerce: 22 units (6 US and 16 OUS); Expanded 3units; Total: 25
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV