Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. M
Summary
The FDA issued a Class II for Philips Azurion Systems R3.0. Includes the following label descriptions and corr by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: 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-.
Details
Source
Device Recall
External ID
Z-1079-2026
Action Date
2026-01-21
Status
Ongoing
Category
device
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.
Lot/Code Info: 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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Quantity Affected: 990 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-08
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1079-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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