Recall Z-2931-2026

Reason for recall

Two software related issues affecting Azurion R2.2.10 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 taken

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