PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;

On May 28, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. - Avoid rapidly pressing and releasing the footswitch pedals. - In case X-ray functionality is not available following the situations described in this letter, perform a cold system restart of the system, as follows: 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: Do not operate any of the controls while the system is powering on, as this may inhibit the start-up process - In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. - Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. - 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 this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken. - If you experience the issue described in this letter, please report it to your local Philips representative. 5. Actions planned by Philips IGT Systems to correct the issue Philips will address the identified issue by implementing a software update in all affected systems. For systems featuring an Interventional Workspot and/or EchoNavigator, Philips will upgrade the Interventional Workspo

• FDA enforcement recordOfficial FDA database entry for Z-1969-2025
• FDA 510(k) clearance · K172822The device's official FDA premarket clearance record
• FDA 510(k) clearance · K181830The device's official FDA premarket clearance record
• FDA 510(k) clearance · K200917The device's official FDA premarket clearance record
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.