Class 2 Device Recall Azurion R2.1

• Date Initiated by Firm: December 12, 2023
• Date Posted: January 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0835-2024
• Recall Event ID: 93755
• 510(K)Number: K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion 7M20 - 722079, 722224; Azurion 3 M15 (China) - 722280
• Code Information: System Product Name - UDI-DI Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890; Azurion 3M15 - 00884838085282, 00884838099210; Azurion 5M12 - 00884838099227; Azurion 5M20 - 00884838099234; Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265; Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883; Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890; Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890; Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276; Software Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2
• FEI Number: 3002807880
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: On December 12, 2023, the firm notified customers via certified mailing of URGENT Medical Device Correction letters. Customers may identify affected products by the system product name and model number, which can be found on the System Identification Label located on the system stand. The software version of the Philips Azurion system can be identified during start-up. Customers were advised to keep the number of studies in the patient database as low as possible, but at least below 500. Customers should keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system. Ensure that all users of the system are notified of the issue. Philips is working on a software release that will correct this issue. Philips representatives will contact affected customers to schedule the correction. Please contact your local Philips representative for further information or support concerning this issue.
• Quantity in Commerce: 1,799 US; 5,747 OUS
• Distribution: Worldwide - 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