Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models:...
FDA Device Recall #Z-1079-2026 — Class II — December 8, 2025
Recall Summary
| Recall Number | Z-1079-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 8, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best |
| Product Type | Devices |
| Quantity | 990 units |
Product 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.
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22. 3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75, (01)00884838116740(21)33, (01)00884838116740(21)47, (01)00884838116740(21)60, (01)00884838116740(21)53, (01)00884838116740(21)45, (01)00884838116740(21)61, (01)00884838116740(21)34, (01)00884838116740(21)54, (01)00884838116740(21)35, (01)00884838116740(21)49, (01)00884838116740(21)32, (01)00884838116740(21)28, (01)00884838116740(21)27, (01)00884838116740(21)26, (01)00884838116740(21)51, (01)00884838116740(21)11, (01)00884838116740(21)20, (01)00884838116740(21)41, (01)00884838116740(21)52, (01)00884838116740(21)3. 4. Model Number: 722232. UDI Numbers: (01)00884838116757(21)61, (01)00884838116757(21)60, (01)00884838116757(21)5, (01)00884838116757(21)49, (01)00884838116757(21)2, (01)00884838116757(21)91, (01)00884838116757(21)33, (01)00884838116757(21)34, (01)00884838116757(21)48, (01)00884838116757(21)46, (01)00884838116757(21)23, (01)00884838116757(21)43, (01)00884838116757(21)36, (01)00884838116757(21)96, (01)00884838116757(21)95, (01)00884838116757(21)10, (01)00884838116757(21)76, (01)00884838116757(21)42, (01)00884838116757(21)6, (01)00884838116757(21)77, (01)00884838116757(21)3, (01)00884838116757(21)1, (01)00884838116757(21)56, (01)00884838116757(21)51, (01)00884838116757(21)44, (01)00884838116757(21)30, (01)00884838116757(21)29, (01)00884838116757(21)28, (01)00884838116757(21)102, (01)00884838116757(21)19, (01)00884838116757(21)8, (01)00884838116757(21)81, (01)00884838116757(21)20, (01)00884838116757(21)16, (01)00884838116757(21)11, (01)00884838116757(21)112, (01)00884838116757(21)63, (01)00884838116757(21)68, (01)00884838116757(21)32, (01)00884838116757(21)35, (01)00884838116757(21)122, (01)00884838116757(21)14, (01)00884838116757(21)82, (01)00884838116757(21)13, (01)00884838116757(21)50, (01)00884838116757(21)57, (01)00884838116757(21)58, (01)00884838116757(21)4, (01)00884838116757(21)105, (01)00884838116757(21)75, (01)00884838116757(21)121, (01)00884838116757(21)120, (01)00884838116757(21)71, (01)00884838116757(21)72, (01)00884838116757(21)73, (01)00884838116757(21)70, (01)00884838116757(21)69, (01)00884838116757(21)37. 5. Model Number: 722235. UDI Numbers: (01)00884838116788(21)88, (01)00884838116788(21)43, (01)00884838116788(21)12, (01)00884838116788(21)102, (01)00884838116788(21)127, (01)00884838116788(21)57, (01)00884838116788(21)55, (01)00884838116788(21)11, (01)00884838116788(21)76, (01)00884838116788(21)71, (01)00884838116788(21)59, (01)00884838116788(21)77, (01)00884838116788(21)89, (01)00884838116788(21)56, (01)00884838116788(21)99, (01)00884838116788(21)30, (01)00884838116788(21)84, (01)00884838116788(21)82, (01)00884838116788(21)83, (01)00884838116788(21)93, (01)00884838116788(21)31, (01)00884838116788(21)47, (01)00884838116788(21)3, (01)00884838116788(21)13, (01)00884838116788(21)10, (01)00884838116788(21)74, (01)00884838116788(21)98, (01)00884838116788(21)40, (01)00884838116788(21)81, (01)00884838116788(21)66, (01)00884838116788(21)63, (01)00884838116788(21)67, (01)00884838116788(21)64, (01)00884838116788(21)42, (01)00884838116788(21)65, (01)00884838116788(21)58, (01)00884838116788(21)53, (01)00884838116788(21)52, (01)00884838116788(21)49, (01)00884838116788(21)44, (01)00884838116788(21)35, (01)00884838116788(21)45, (01)00884838116788(21)39, (01)00884838116788(21)25, (01)00884838116788(21)34, (01)00884838116788(21)17, (01)00884838116788(21)24, (01)00884838116788(21)19, (01)00884838116788(21)33, (01)00884838116788(21)18, (01)00884838116788(21)9, (01)00884838116788(21)28, (01)00884838116788(21)8, (01)00884838116788(21)23, (01)00884838116788(21)21, (01)00884838116788(21)6, (01)00884838116788(21)7, (01)00884838116788(21)5, (01)00884838116788(21)108, (01)00884838116788(21)109, (01)00884838116788(21)107, (01)00884838116788(21)106, (01)00884838116788(21)4, (01)00884838116788(21)41, (01)00884838116788(21)72, (01)00884838116788(21)70, (01)00884838116788(21)54, (01)00884838116788(21)20, (01)00884838116788(21)14, (01)00884838116788(21)126, (01)00884838116788(21)105, (01)00884838116788(21)94. 6. Model Number: 722236. UDI Numbers: (01)00884838116801(21)43, (01)00884838116801(21)42, (01)00884838116801(21)121, (01)00884838116801(21)50, (01)00884838116801(21)183, (01)00884838116801(21)32, (01)00884838116801(21)38, (01)00884838116801(21)197, (01)00884838116801(21)335, (01)00884838116801(21)325, (01)00884838116801(21)116, (01)00884838116801(21)191, (01)00884838116801(21)235, (01)00884838116801(21)22, (01)00884838116801(21)204, (01)00884838116801(21)249, (01)00884838116801(21)159, (01)00884838116801(21)40, (01)00884838116801(21)233, (01)00884838116801(21)194, (01)00884838116801(21)205, (01)00884838116801(21)276, (01)00884838116801(21)378, (01)00884838116801(21)20, (01)00884838116801(21)81, (01)00884838116801(21)51, (01)00884838116801(21)288, (01)00884838116801(21)25, (01)00884838116801(21)54, (01)00884838116801(21)186, (01)00884838116801(21)21, (01)00884838116801(21)68, (01)00884838116801(21)99, (01)00884838116801(21)208, (01)00884838116801(21)31, (01)00884838116801(21)230, (01)00884838116801(21)203, (01)00884838116801(21)180, (01)00884838116801(21)37, (01)00884838116801(21)342, (01)00884838116801(21)24, (01)00884838116801(21)221, (01)00884838116801(21)17, (01)00884838116801(21)252, (01)00884838116801(21)150, (01)00884838116801(21)60, (01)00884838116801(21)200, (01)00884838116801(21)226, (01)00884838116801(21)118, (01)00884838116801(21)127, (01)00884838116801(21)26, (01)00884838116801(21)36, (01)00884838116801(21)133, (01)00884838116801(21)345, (01)00884838116801(21)134, (01)00884838116801(21)131, (01)00884838116801(21)39, (01)00884838116801(21)231, (01)00884838116801(21)158, (01)00884838116801(21)48, (01)00884838116801(21)227, (01)00884838116801(21)148, (01)00884838116801(21)147, (01)00884838116801(21)272, (01)00884838116801(21)273, (01)00884838116801(21)100, (01)00884838116801(21)224, (01)00884838116801(21)164, (01)00884838116801(21)163, (01)00884838116801(21)170, (01)00884838116801(21)44, (01)00884838116801(21)46, (01)00884838116801(21)113, (01)00884838116801(21)216, (01)00884838116801(21)278, (01)00884838116801(21)102, (01)00884838116801(21)8, (01)00884838116801(21)169, (01)00884838116801(21)338, (01)00884838116801(21)117, (01)00884838116801(21)29, (01)00884838116801(21)34, (01)00884838116801(21)10, (01)00884838116801(21)126, (01)00884838116801(21)237, (01)00884838116801(21)125, (01)00884838116801(21)154, (01)00884838116801(21)157, (01)00884838116801(21)30, (01)00884838116801(21)67, (01)00884838116801(21)292, (01)00884838116801(21)289, (01)00884838116801(21)277, (01)00884838116801(21)244, (01)00884838116801(21)181, (01)00884838116801(21)264, (01)00884838116801(21)232, (01)00884838116801(21)207, (01)00884838116801(21)192, (01)00884838116801(21)132, (01)00884838116801(21)128, (01)00884838116801(21)160, (01)00884838116801(21)94, (01)00884838116801(21)86, (01)00884838116801(21)41, (01)00884838116801(21)27, (01)00884838116801(21)259, (01)00884838116801(21)251, (01)00884838116801(21)261, (01)00884838116801(21)57, (01)00884838116801(21)240, (01)00884838116801(21)107, (01)00884838116801(21)172, (01)00884838116801(21)142, (01)00884838116801(21)109, (01)00884838116801(21)55, (01)00884838116801(21)171, (01)00884838116801(21)155, (01)00884838116801(21)175, (01)00884838116801(21)111, (01)00884838116801(21)88, (01)00884838116801(21)104, (01)00884838116801(21)152, (01)00884838116801(21)124, (01)00884838116801(21)103, (01)00884838116801(21)90, (01)00884838116801(21)70, (01)00884838116801(21)153, (01)00884838116801(21)106, (01)00884838116801(21)151, (01)00884838116801(21)144, (01)00884838116801(21)141, (01)00884838116801(21)76, (01)00884838116801(21)112, (01)00884838116801(21)105, (01)00884838116801(21)85, (01)00884838116801(21)62, (01)00884838116801(21)52, (01)00884838116801(21)75, (01)00884838116801(21)92, (01)00884838116801(21)89, (01)00884838116801(21)108, (01)00884838116801(21)59, (01)00884838116801(21)73, (01)00884838116801(21)84, (01)00884838116801(21)69, (01)00884838116801(21)83, (01)00884838116801(21)80, (01)00884838116801(21)64, (01)00884838116801(21)74, (01)00884838116801(21)53, (01)00884838116801(21)49, (01)00884838116801(21)329, (01)00884838116801(21)130, (01)00884838116801(21)326, (01)00884838116801(21)168, (01)00884838116801(21)145, (01)00884838116801(21)146, (01)00884838116801(21)98, (01)00884838116801(21)96, (01)00884838116801(21)93, (01)00884838116801(21)258, (01)00884838116801(21)56, (01)00884838116801(21)91, (01)00884838116801(21)271, (01)00884838116801(21)201, (01)00884838116801(21)123, (01)00884838116801(21)162, (01)00884838116801(21)122, (01)00884838116801(21)114, (01)00884838116801(21)63, (01)00884838116801(21)374, (01)00884838116801(21)357, (01)00884838116801(21)348, (01)00884838116801(21)347, (01)00884838116801(21)352, (01)00884838116801(21)322, (01)00884838116801(21)330, (01)00884838116801(21)321, (01)00884838116801(21)188, (01)00884838116801(21)283, (01)00884838116801(21)285, (01)00884838116801(21)284, (01)00884838116801(21)269, (01)00884838116801(21)193, (01)00884838116801(21)173, (01)00884838116801(21)311, (01)00884838116801(21)156, (01)00884838116801(21)219, (01)00884838116801(21)167, (01)00884838116801(21)33, (01)00884838116801(21)268, (01)00884838116801(21)23, (01)00884838116801(21)361, (01)00884838116801(21)242, (01)00884838116801(21)223, (01)00884838116801(21)234, (01)00884838116801(21)182, (01)00884838116801(21)189, (01)00884838116801(21)165, (01)00884838116801(21)82, (01)00884838116801(21)66, (01)00884838116801(21)13. 7. Model Number: 722233. UDI Numbers: (01)00884838116764(21)118, (01)00884838116764(21)96, (01)00884838116764(21)259, (01)00884838116764(21)169, (01)00884838116764(21)108, (01)00884838116764(21)212, (01)00884838116764(21)267, (01)00884838116764(21)214, (01)00884838116764(21)147, (01)00884838116764(21)153, (01)00884838116764(21)111, (01)00884838116764(21)122, (01)00884838116764(21)124, (01)00884838116764(21)127, (01)00884838116764(21)59, (01)00884838116764(21)172, (01)00884838116764(21)64, (01)00884838116764(21)170, (01)00884838116764(21)41, (01)00884838116764(21)103, (01)00884838116764(21)144, (01)00884838116764(21)219, (01)00884838116764(21)218, (01)00884838116764(21)192, (01)00884838116764(21)30, (01)00884838116764(21)189, (01)00884838116764(21)186, (01)00884838116764(21)17, (01)00884838116764(21)9, (01)00884838116764(21)245, (01)00884838116764(21)57, (01)00884838116764(21)32, (01)00884838116764(21)203, (01)00884838116764(21)205, (01)00884838116764(21)204, (01)00884838116764(21)184, (01)00884838116764(21)162, (01)00884838116764(21)18, (01)00884838116764(21)83, (01)00884838116764(21)84, (01)00884838116764(21)88, (01)00884838116764(21)76, (01)00884838116764(21)137, (01)00884838116764(21)85, (01)00884838116764(21)86, (01)00884838116764(21)87, (01)00884838116764(21)46, (01)00884838116764(21)47, (01)00884838116764(21)26, (01)00884838116764(21)234, (01)00884838116764(21)200, (01)00884838116764(21)250, (01)00884838116764(21)201, (01)00884838116764(21)123, (01)00884838116764(21)235, (01)00884838116764(21)68, (01)00884838116764(21)14, (01)00884838116764(21)82, (01)00884838116764(21)27, (01)00884838116764(21)38, (01)00884838116764(21)37, (01)00884838116764(21)8, (01)00884838116764(21)145, (01)00884838116764(21)112, (01)00884838116764(21)95, (01)00884838116764(21)173, (01)00884838116764(21)202, (01)00884838116764(21)101, (01)00884838116764(21)165, (01)00884838116764(21)166, (01)00884838116764(21)97, (01)00884838116764(21)81, (01)00884838116764(21)61, (01)00884838116764(21)31, (01)00884838116764(21)29, (01)00884838116764(21)109, (01)00884838116764(21)279, (01)00884838116764(21)260, (01)00884838116764(21)221, (01)00884838116764(21)178, (01)00884838116764(21)181, (01)00884838116764(21)159, (01)00884838116764(21)117, (01)00884838116764(21)141, (01)00884838116764(21)120, (01)00884838116764(21)273, (01)00884838116764(21)163, (01)00884838116764(21)272, (01)00884838116764(21)174, (01)00884838116764(21)249, (01)00884838116764(21)78, (01)00884838116764(21)133, (01)00884838116764(21)102, (01)00884838116764(21)106, (01)00884838116764(21)104, (01)00884838116764(21)80, (01)00884838116764(21)77, (01)00884838116764(21)206, (01)00884838116764(21)67, (01)00884838116764(21)39, (01)00884838116764(21)15, (01)00884838116764(21)13, (01)00884838116764(21)179, (01)00884838116764(21)180, (01)00884838116764(21)136, (01)00884838116764(21)129, (01)00884838116764(21)222, (01)00884838116764(21)149, (01)00884838116764(21)148, (01)00884838116764(21)146, (01)00884838116764(21)5, (01)00884838116764(21)51, (01)00884838116764(21)19, (01)00884838116764(21)7, (01)00884838116764(21)6, (01)00884838116764(21)231, (01)00884838116764(21)107, (01)00884838116764(21)91, (01)00884838116764(21)89, (01)00884838116764(21)90, (01)00884838116764(21)71, (01)00884838116764(21)48, (01)00884838116764(21)74, (01)00884838116764(21)62, (01)00884838116764(21)55, (01)00884838116764(21)50, (01)00884838116764(21)43, (01)00884838116764(21)40, (01)00884838116764(21)11, (01)00884838116764(21)35, (01)00884838116764(21)60, (01)00884838116764(21)28, (01)00884838116764(21)20, (01)00884838116764(21)12, (01)00884838116764(21)138, (01)00884838116764(21)139, (01)00884838116764(21)58, (01)00884838116764(21)257, (01)00884838116764(21)160, (01)00884838116764(21)24, (01)00884838116764(21)268, (01)00884838116764(21)284, (01)00884838116764(21)291, (01)00884838116764(21)238, (01)00884838116764(21)225, (01)00884838116764(21)217, (01)00884838116764(21)211, (01)00884838116764(21)16, (01)00884838116764(21)110, (01)00884838116764(21)183, (01)00884838116764(21)143, (01)00884838116764(21)134, (01)00884838116764(21)44, (01)00884838116764(21)197. 8. Model Number: 722234. UDI Numbers: (01)00884838116771(21)626, (01)00884838116771(21)320, (01)00884838116771(21)256, (01)00884838116771(21)321, (01)00884838116771(21)437, (01)00884838116771(21)101, (01)00884838116771(21)616, (01)00884838116771(21)418, (01)00884838116771(21)426, (01)00884838116771(21)87, (01)00884838116771(21)420, (01)00884838116771(21)827, (01)00884838116771(21)716, (01)00884838116771(21)607, (01)00884838116771(21)183, (01)00884838116771(21)345, (01)00884838116771(21)520, (01)00884838116771(21)662, (01)00884838116771(21)327, (01)00884838116771(21)524, (01)00884838116771(21)191, (01)00884838116771(21)201, (01)00884838116771(21)449, (01)00884838116771(21)435, (01)00884838116771(21)657, (01)00884838116771(21)171, (01)00884838116771(21)124, (01)00884838116771(21)123, (01)00884838116771(21)79, (01)00884838116771(21)409, (01)00884838116771(21)70, (01)00884838116771(21)55, (01)00884838116771(21)68, (01)00884838116771(21)780, (01)00884838116771(21)794, (01)00884838116771(21)500, 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Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 30, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model N... | Apr 30, 2026 |
| Z-2227-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description... | Apr 28, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an ... | Apr 28, 2026 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.