Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079

Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart

Philips issued URGENT Medical Device Correction Letter to US consignees on July 15th, 2024, via certified mail. Letter states reason for recall, health risk and action to take: Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Should you experience a loss of imaging (X-ray) functionality or a prolonged system restart time, call your local Philips representative to report the event. " Complete and return the attached response form (page 4) to Philips promptly and no later than 30 days from receipt. This confirms that the users of the system have reviewed and understand this Urgent Medical Device Correction and required actions to be taken. Philips is working on a software release (R2.2.10) that will correct these two issues (ref. FCOs: FCO72200548, FCO72200580, FCO72200582, FCO72200583, FCO72200584, FCO72200592). For those systems that have an Interventional Workspot (IW) and/or EchoNavigator, Philips will upgrade the software version of the IW and/or EchoNavigator to maintain compatibility with the updated Philips Azurion system software (R2.2.10). Your local Philips representative will contact you to schedule a visit to install the software update once available. Philips expects this software to be released by Q1 2025. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800- 722-9377 (Philips Customer Care Solutions Center).