Class 2 Device Recall Azurion

• Date Initiated by Firm: July 16, 2026
• Date Posted: August 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2932-2026
• Recall Event ID: 99423
• 510(K)Number: K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
• Code Information: UDI: (01)00884838116757(21)5, (01)00884838116771(21)686, (01)00884838116771(21)521, (01)00884838116771(21)812, (01)00884838116771(21)163, (01)00884838116801(21)127, (01)00884838116757(21)34, (01)00884838116733(21)61, (01)00884838116764(21)226, (01)00884838116771(21)327, (01)00884838116764(21)277, (01)00884838116771(21)780, (01)00884838116771(21)429, (01)00884838116764(21)276, (01)00884838116788(21)87, (01)00884838116801(21)37, (01)00884838116771(21)362, (01)00884838116771(21)502, (01)00884838116740(21)77, (01)00884838116757(21)106, (01)00884838116771(21)222, (01)00884838116771(21)545, (01)00884838116801(21)159, (01)00884838116801(21)345, (01)00884838116771(21)987, (01)00884838116771(21)457, (01)00884838116801(21)136, (01)00884838116757(21)49, (01)00884838116771(21)803, (01)00884838116771(21)901, (01)00884838116771(21)347, (01)00884838116764(21)335, (01)00884838116801(21)199, (01)00884838116801(21)24, (01)00884838116771(21)902, (01)00884838116771(21)529, 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• FEI Number: 3042175844
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 6; Best Netherlands
• Manufacturer Reason for Recall: Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications.
• FDA Determined Cause: Software design
• Action: Philips issued an URGENT Medical Device Correction to its consignees on 7/16/2026 via certified mailing. The notice explained the issues, potential harms associated with the issues, and provide instructions for the safe operations of the device pending a software update. The instructions are as follows: Issue 1: Image quality degradation If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions for Use: o On the Review Module, press and hold Power Off . o Release the button when the indicator light begins to flash. o When the indicator light stops flashing, wait for 10 seconds. o On the Review Module, press and hold Power On . NOTE: A cold restart of the system takes up to 6 minutes from initiation of the cold restart until all system functionality is available. " Issue 2: Loss of geometry movements If loss of geometry movements is observed, restart the geometry following the steps described in the Instructions for Use: o On the Control Module, press the Emergency Stop button. o On the Review Module, press the Power On button for approximately 2 seconds. NOTE: A geometry restart may take up to 2 minutes to complete. " Ensure this notice is distributed to all relevant users of the system. " Post this notice near affected devices for ease of reference, where applicable. " If the affected device has been transferred to another organization, please forward this notice to that organization and inform Philips through your local representative. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. " If you experience an issue described in this letter, please report it to your local Philips representative. " Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt. Completing t
• Quantity in Commerce: 2016 units
• Distribution: Worldwide 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