Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Recall
- Recall Number
- Z-1079-2026
- Event Number
- 98071
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands
- FEI Number
- 3002807880
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- December 8, 2025
- Posted
- January 14, 2026
Description
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
Philips notified consignees on about 12/08/2025 via emailed URGENT Medical Device Correction letter. The letter informed consignees that they have identified nine (9) software issues affecting Azurion R3.0 systems that may result in loss of imaging (X-ray) functionality, and/or loss of motorized movement, and/or incorrect image content, and/or loss of data. Consignees were instructed to identify all affected units on hand, ensure all users of the affected units are aware of the issue and notify any customers if the unit has been transferred or distributed. Consignees were also instructed to keep the notification with documentation of the system until the issue is resolved, and complete and return the response form. If any of the nine issues are encountered, consignees were asked to contact their local Philips representative and the letter provided recommended actions. Philips will address the identified issues by implementing software updates in all affected systems. Philips expects to have software update 3.1.5 (FCO72200613), that resolves issues 1 - 7, released by Q1 2026 (subject to regulatory clearance). The Misalignment of Marker Tool Overlay (issue 8) and Longitudinal Position Error (issue 9) will not be resolved with software update 3.1.5. The solution for those issues is planned for Q4 2026 (subject to regulatory clearance) with software update 3.1.15 (FC072200684). Local Philips representatives will contact each consignee to schedule visits to install the software updates once available.
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
990 units