Class 2 Device Recall Azurion R2.1

• Date Initiated by Firm: September 24, 2021
• Create Date: November 24, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0238-2022
• Recall Event ID: 89020
• 510(K)Number: K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
• Code Information: Azurion 2.1(L1) and 2.1(L2)
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips Healthcare; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: DUSTY LEPPERT, CHP; 978-228-0190
• Manufacturer Reason for Recall: 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a 3D-RA scan, the detector of the Philips Azurion system must be positioned in portrait or landscape orientation with an angle of 0 or +/-90 degrees relative to the 3D scan direction. Philips has discovered that Azurion releases 2.1(L1) and 2.1(L2) allow creation of a 3D-RA scan with a deviating detector orientation of up to 3 degrees from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees), relative to the 3D scan direction. 3D-RA scans with a deviating detector orientation of ore than 1.0 degree from the exact portrait or landscape orientation (i.e., at 0 or +/-90 degrees) cannot be reconstructed with the 3D-RA reconstruction software.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Philips will inform customers of the issue via an Electronic Product Radiation Correction notification. The letter identified the affected product, problem and actions to be taken. Philips Field Service Engineers will schedule an appointment with customers to install the software update. For questions contact your Philips representative at 1-800-722-9377.
• Quantity in Commerce: 226 units
• Distribution: US Nationwide distribution
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB