| | Class 2 Device Recall Azurion |  |
| Date Initiated by Firm | April 30, 2026 |
|---|
| Date Posted | May 28, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2258-2026 |
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| Recall Event ID |
98826 |
| 510(K)Number | K102005 K130638 K130842 K133292 K141979 K161563 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224). |
|---|
| Code Information |
1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)149, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)116, (01)00884838085275(21)151, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)105, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54, (01)00884838085275(21)46, (01)00884838085275(21)26, (01)00884838085275(21)71, (01)00884838085275(21)106, (01)00884838085275(21)83, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)107, (01)00884838085275(21)85, (01)00884838085275(21)89, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, (01)00884838085275(21)113;
2. Azurion 3 M12; Model: 722221; UDI: (01)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838099203(21)6, (01)00884838099203(21)9, (01)00884838099203(21)4, (01)00884838099203(21)23, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)2, (01)00884838099203(21)5, (01)00884838099203(21)1, (01)00884838099203(21)11;
3. Azurion 3 M15; Model: 722064; UDI: (01)00884838085282(21)209, (01)00884838085282(21)238, (01)00884838085282(21)201, (01)00884838085282(21)258, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838085282(21)314, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)267, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)162, (01)00884838085282(21)161, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)268, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)89, (01)00884838085282(21)303, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)263, (01)00884838085282(21)60, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)257, (01)00884838085282(21)280, (01)00884838085282(21)9, (01)00884838085282(21)277, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)185, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, (01)00884838085282(21)180, (01)00884838085282(21)250, (01)00884838085282(21)186, (01)00884838085282(21)246, (01)00884838085282(21)282, (01)00884838085282(21)354, (01)00884838085282(21)274, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)276, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)149, (01)00884838085282(21)288, (01)00884838085282(21)287, (01)00884838085282(21)231, (01)00884838085282(21)150, (01)00884838085282(21)230, (01)00884838085282(21)233, (01)00884838085282(21)197, (01)00884838085282(21)44, (01)00884838085282(21)289, (01)00884838085282(21)176, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)69, (01)00884838085282(21)39, (01)00884838085282(21)45, (01)00884838085282(21)66, (01)00884838085282(21)40, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)70, (01)00884838085282(21)50, (01)00884838085282(21)138, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)321, (01)00884838085282(21)237, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)342, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)391, (01)00884838085282(21)98, (01)00884838085282(21)320, (01)00884838085282(21)79, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)311, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)228, (01)00884838085282(21)252, (01)00884838085282(21)91, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)309, (01)00884838085282(21)251, (01)00884838085282(21)387, (01)00884838085282(21)269, (01)00884838085282(21)11, (01)00884838085282(21)147, (01)00884838085282(21)262, (01)00884838085282(21)133, (01)00884838085282(21)337, (01)00884838085282(21)275, (01)00884838085282(21)412, (01)00884838085282(21)405, (01)00884838085282(21)396, (01)00884838085282(21)247, (01)00884838085282(21)406, (01)00884838085282(21)340, (01)00884838085282(21)393, (01)00884838085282(21)322, (01)00884838085282(21)385, (01)00884838085282(21)333, (01)00884838085282(21)236, (01)00884838085282(21)234, (01)00884838085282(21)413, (01)00884838085282(21)7, (01)00884838085282(21)308, (01)00884838085282(21)225, (01)00884838085282(21)344, (01)00884838085282(21)389, (01)00884838085282(21)265, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)341, (01)00884838085282(21)100, (01)00884838085282(21)51, (01)00884838085282(21)118, (01)00884838085282(21)62, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)272, (01)00884838085282(21)110, (01)00884838085282(21)59, (01)00884838085282(21)167, (01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)41, (01)00884838085282(21)168, (01)00884838085282(21)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)302, (01)00884838085282(21)86, (01)00884838085282(21)317, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)312, (01)00884838085282(21)143, (01)00884838085282(21)403, (01)00884838085282(21)386, (01)00884838085282(21)226, (01)00884838085282(21)43, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)285, (01)00884838085282(21)338, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)327, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)241, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)199, (01)00884838085282(21)188, (01)00884838085282(21)296, (01)00884838085282(21)172, (01)00884838085282(21)283, (01)00884838085282(21)306, (01)00884838085282(21)210, (01)00884838085282(21)134, (01)00884838085282(21)255, (01)00884838085282(21)207, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)189, (01)00884838085282(21)117, (01)00884838085282(21)313, (01)00884838085282(21)187, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108, (01)00884838085282(21)37, (01)00884838085282(21)72;
4. Azurion 3 M15; Model: 722222; UDI: (01)00884838099210(21)12, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838099210(21)35, (01)00884838099210(21)21, (01)00884838099210(21)18, (01)00884838099210(21)24, (01)00884838099210(21)9, (01)00884838099210(21)5, (01)00884838099210(21)14, (01)00884838099210(21)10, (01)00884838099210(21)13;
5. Azurion 5 M12; Model: 722227; UDI: (01)00884838099227(21)23, (01)00884838099227(21)19, (01)00884838099227(21)5, (01)00884838099227(21)6, (01)00884838099227(21)7, (01)00884838099227(21)36, (01)00884838099227(21)18, (01)00884838099227(21)15, (01)00884838099227(21)14, (01)00884838099227(21)17, (01)00884838099227(21)2, (01)00884838099227(21)1, (01)00884838099227(21)12, (01)00884838099227(21)3, (01)00884838099227(21)11, (01)00884838099227(21)13, (01)00884838099227(21)4;
6. Azurion 5 M20; Model: 722228; UDI: (01)00884838099234(21)10, (01)00884838099234(21)18, (01)00884838099234(21)23, (01)00884838099234(21)3, (01)00884838099234(21)16, (01)00884838099234(21)22, (01)00884838099234(21)4, (01)00884838099234(21)12, (01)00884838099234(21)14, (01)00884838099234(21)7, (01)00884838099234(21)5;
7. Azurion 7 B12; Model: 722067; UDI: (01)00884838085350(21)42, (01)00884838085350(21)172, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)250, (01)00884838085350(21)103, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)114, (01)00884838085350(21)225, (01)00884838085350(21)69, (01)00884838085350(21)214, (01)00884838085350(21)41, (01)00884838085350(21)221, (01)00884838085350(21)98, (01)00884838085350(21)81, (01)00884838085350(21)123, (01)00884838085350(21)46, (01)00884838085350(21)115, (01)00884838085350(21)150, (01)00884838085350(21)163, (01)00884838085350(21)131, (01)00884838085350(21)71, (01)00884838085350(21)75, (01)00884838085350(21)147, (01)00884838085350(21)132, (01)00884838085350(21)244, (01)00884838085350(21)104, (01)00884838085350(21)208, (01)00884838085350(21)36, (01)00884838085350(21)234, (01)00884838085350(21)141, (01)00884838085350(21)70, (01)00884838085350(21)26, (01)00884838085350(21)148, (01)00884838085350(21)133, (01)00884838085350(21)57, (01)00884838085350(21)128, (01)00884838085350(21)188, (01)00884838085350(21)151, (01)00884838085350(21)68, (01)00884838085350(21)233, (01)00884838085350(21)111, (01)00884838085350(21)255, (01)00884838085350(21)43, (01)00884838085350(21)33, (01)00884838085350(21)22, (01)00884838085350(21)146, (01)00884838085350(21)270, (01)00884838085350(21)238, (01)00884838085350(21)187, (01)00884838085350(21)74, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)251, (01)00884838085350(21)237, (01)00884838085350(21)222, (01)00884838085350(21)262, (01)00884838085350(21)29, (01)00884838085350(21)59, (01)00884838085350(21)209, (01)00884838085350(21)260, (01)00884838085350(21)191, (01)00884838085350(21)95, (01)00884838085350(21)218, (01)00884838085350(21)231, (01)00884838085350(21)169, (01)00884838085350(21)127, (01)00884838085350(21)211, (01)00884838085350(21)212, (01)00884838085350(21)210, (01)00884838085350(21)213, (01)00884838085350(21)30, (01)00884838085350(21)206, (01)00884838085350(21)23, (01)00884838085350(21)203, (01)00884838085350(21)138, (01)00884838085350(21)34, (01)00884838085350(21)53, (01)00884838085350(21)113, (01)00884838085350(21)254, (01)00884838085350(21)140, (01)00884838085350(21)143, (01)00884838085350(21)144, (01)00884838085350(21)142, (01)00884838085350(21)266, (01)00884838085350(21)60, (01)00884838085350(21)97, (01)00884838085350(21)45, (01)00884838085350(21)107, (01)00884838085350(21)112, (01)00884838085350(21)101, (01)00884838085350(21)100, (01)00884838085350(21)168, (01)00884838085350(21)235, (01)00884838085350(21)272, (01)00884838085350(21)58, (01)00884838085350(21)47, (01)00884838085350(21)176, (01)00884838085350(21)64, (01)00884838085350(21)156, (01)00884838085350(21)52, (01)00884838085350(21)232, (01)00884838085350(21)55, (01)00884838085350(21)54, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)202, (01)00884838085350(21)149, (01)00884838085350(21)243, (01)00884838085350(21)32, (01)00884838085350(21)207, (01)00884838085350(21)76, (01)00884838085350(21)108, (01)00884838085350(21)226, (01)00884838085350(21)48, (01)00884838085350(21)264, (01)00884838085350(21)102, (01)00884838085350(21)84, (01)00884838085350(21)105, (01)00884838085350(21)99, (01)00884838085350(21)21, (01)00884838085350(21)159, (01)00884838085350(21)49, (01)00884838085350(21)185, (01)00884838085350(21)51, (01)00884838085350(21)239, (01)00884838085350(21)40, (01)00884838085350(21)94, (01)00884838085350(21)63, (01)00884838085350(21)96, (01)00884838085350(21)129, (01)00884838085350(21)245, (01)00884838085350(21)186, (01)00884838085350(21)130, (01)00884838085350(21)252, (01)00884838085350(21)161, (01)00884838085350(21)120, (01)00884838085350(21)170, (01)00884838085350(21)197, (01)00884838085350(21)195, (01)00884838085350(21)196, (01)00884838085350(21)171, (01)00884838085350(21)193, (01)00884838085350(21)80, (01)00884838085350(21)28, (01)00884838085350(21)229, (01)00884838085350(21)145, (01)00884838085350(21)79, (01)00884838085350(21)93, (01)00884838085350(21)137, (01)00884838085350(21)50, (01)00884838085350(21)44, (01)00884838085350(21)38, (01)00884838085350(21)175, (01)00884838085350(21)227, (01)00884838085350(21)167, (01)00884838085350(21)78, (01)00884838085350(21)86, (01)00884838085350(21)91, (01)00884838085350(21)189, (01)00884838085350(21)198, (01)00884838085350(21)37, (01)00884838085350(21)72, (01)00884838085350(21)199, (01)00884838085350(21)88, (01)00884838085350(21)27, (01)00884838085350(21)121, (01)00884838085350(21)179, (01)00884838085350(21)183, (01)00884838085350(21)118, (01)00884838085350(21)117, (01)00884838085350(21)85, (01)00884838085350(21)90, (01)00884838085350(21)89, (01)00884838085350(21)119, (01)00884838085350(21)87, (01)00884838085350(21)31, (01)00884838085350(21)110, (01)00884838085350(21)178, (01)00884838085350(21)73, (01)00884838085350(21)194, (01)00884838085350(21)39, (01)00884838085350(21)56, (01)00884838085350(21)139, (01)00884838085350(21)61,
8. Azurion 7 B12; Model: 722225; UDI: (01)00884838099265(21)29, (01)00884838099265(21)8, (01)00884838099265(21)38, (01)00884838099265(21)14, (01)00884838099265(21)243, (01)00884838099265(21)4, (01)00884838099265(21)30, (01)00884838099265(21)7, (01)00884838099265(21)17, (01)00884838099265(21)31, (01)00884838099265(21)32, (01)00884838099265(21)18, (01)00884838099265(21)19, (01)00884838099265(21)10, (01)00884838099265(21)35, (01)00884838099265(21)36, (01)00884838099265(21)15, (01)00884838099265(21)11, (01)00884838099265(21)21, (01)00884838099265(21)16, (01)00884838099265(21)27, (01)00884838099265(21)12, (01)00884838099265(21)9;
9. Azurion 7 B20; Model: 722068; UDI: (01)00884838085367(21)467, (01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)494, (01)00884838085367(21)95, (01)00884838085367(21)440, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838085367(21)64, (01)00884838085367(21)149, (01)00884838085367(21)153, (01)00884838085367(21)324, (01)00884838085367(21)323, (01)00884838085367(21)320, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)109, (01)00884838085367(21)407, (01)00884838085367(21)239, (01)00884838085367(21)505, (01)00884838085367(21)271, (01)00884838085367(21)443, (01)00884838085367(21)104, (01)00884838085367(21)370, (01)00884838085367(21)322, (01)00884838085367(21)136, (01)00884838085367(21)373, (01)00884838085367(21)442, (01)00884838085367(21)308, (01)00884838085367(21)354, (01)00884838085367(21)75, (01)00884838085367(21)279, (01)00884838085367(21)196, (01)00884838085367(21)510, (01)00884838085367(21)110, (01)00884838085367(21)446, (01)00884838085367(21)78, (01)00884838085367(21)330, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085367(21)285, (01)00884838085367(21)295, (01)00884838085367(21)528, (01)00884838085367(21)329, (01)00884838085367(21)184, (01)00884838085367(21)350, (01)00884838085367(21)304, (01)00884838085367(21)470, (01)00884838085367(21)457, (01)00884838085367(21)472, (01)00884838085367(21)319, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838085367(21)243, (01)00884838085367(21)103, (01)00884838085367(21)261, (01)00884838085367(21)262, (01)00884838085367(21)277, (01)00884838085367(21)150, (01)00884838085367(21)172, (01)00884838085367(21)117, (01)00884838085367(21)130, (01)00884838085367(21)356, (01)00884838085367(21)143, (01)00884838085367(21)146, (01)00884838085367(21)84, (01)00884838085367(21)251, (01)00884838085367(21)469, (01)00884838085367(21)431, (01)00884838085367(21)361, (01)00884838085367(21)76, (01)00884838085367(21)374, (01)00884838085367(21)270, (01)00884838085367(21)114, (01)00884838085367(21)477, (01)00884838085367(21)232, (01)00884838085367(21)137, (01)00884838085367(21)282, (01)00884838085367(21)487, (01)00884838085367(21)413, (01)00884838085367(21)337, (01)00884838085367(21)101, (01)00884838085367(21)213, (01)00884838085367(21)82, (01)00884838085367(21)265, (01)00884838085367(21)275, (01)00884838085367(21)459, (01)00884838085367(21)276, (01)00884838085367(21)62, (01)00884838085367(21)506, (01)00884838085367(21)473, (01)00884838085367(21)417, (01)00884838085367(21)302, (01)00884838085367(21)314, (01)00884838085367(21)88, (01)00884838085367(21)468, (01)00884838085367(21)126, (01)00884838085367(21)211, (01)00884838085367(21)422, (01)00884838085367(21)454, (01)00884838085367(21)410, (01)00884838085367(21)283, (01)00884838085367(21)231, (01)00884838085367(21)466, (01)00884838085367(21)495, (01)00884838085367(21)207, (01)00884838085367(21)167, (01)00884838085367(21)445, (01)00884838085367(21)438, (01)00884838085367(21)289, (01)00884838085367(21)233, (01)00884838085367(21)173, (01)00884838085367(21)536, (01)00884838085367(21)204, (01)00884838085367(21)77, (01)00884838085367(21)313, (01)00884838085367(21)236, (01)00884838085367(21)133, (01)00884838085367(21)481, (01)00884838085367(21)280, (01)00884838085367(21)307, (01)00884838085367(21)210, (01)00884838085367(21)258, (01)00884838085367(21)328, (01)00884838085367(21)199, (01)00884838085367(21)480, (01)00884838085367(21)53, (01)00884838085367(21)72, (01)00884838085367(21)364, (01)00884838085367(21)491, (01)00884838085367(21)423, (01)00884838085367(21)509, (01)00884838085367(21)246, (01)00884838085367(21)142, (01)00884838085367(21)376, (01)00884838085367(21)257, (01)00884838085367(21)140, (01)00884838085367(21)369, (01)00884838085367(21)508, (01)00884838085367(21)97, (01)00884838085367(21)87, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838085367(21)301, (01)00884838085367(21)460, (01)00884838085367(21)478, (01)00884838085367(21)522, (01)00884838085367(21)448, (01)00884838085367(21)242, (01)00884838085367(21)238, (01)00884838085367(21)160, (01)00884838085367(21)83, (01)00884838085367(21)68, (01)00884838085367(21)544, (01)00884838085367(21)230, (01)00884838085367(21)360, (01)00884838085367(21)93, (01)00884838085367(21)36, (01)00884838085367(21)372, (01)00884838085367(21)179, (01)00884838085367(21)306, (01)00884838085367(21)182, (01)00884838085367(21)327, (01)00884838085367(21)244, (01)00884838085367(21)382, (01)00884838085367(21)192, (01)00884838085367(21)428, (01)00884838085367(21)432, (01)00884838085367(21)215, (01)00884838085367(21)338, (01)00884838085367(21)399, (01)00884838085367(21)339, (01)00884838085367(21)316, (01)00884838085367(21)555, (01)00884838085367(21)347, (01)00884838085367(21)148, (01)00884838085367(21)134, (01)00884838085367(21)38, (01)00884838085367(21)158, (01)00884838085367(21)318, (01)00884838085367(21)518, (01)00884838085367(21)250, (01)00884838085367(21)118, (01)00884838085367(21)336, (01)00884838085367(21)185, (01)00884838085367(21)206, (01)00884838085367(21)50, (01)00884838085367(21)489, (01)00884838085367(21)521, (01)00884838085367(21)37, (01)00884838085367(21)79, (01)00884838085367(21)529, (01)00884838085367(21)254, (01)00884838085367(21)427, (01)00884838085367(21)394, (01)00884838085367(21)71, (01)00884838085367(21)47, (01)00884838085367(21)534, (01)00884838085367(21)292, (01)00884838085367(21)497, (01)00884838085367(21)35, (01)00884838085367(21)293, (01)00884838085367(21)227, (01)00884838085367(21)359, (01)00884838085367(21)527, (01)00884838085367(21)387, (01)00884838085367(21)168, (01)00884838085367(21)128, (01)00884838085367(21)129, (01)00884838085367(21)396, (01)00884838085367(21)486, (01)00884838085367(21)69, (01)00884838085367(21)453, (01)00884838085367(21)174, (01)00884838085367(21)484, (01)00884838085367(21)483, (01)00884838085367(21)334, (01)00884838085367(21)425, (01)00884838085367(21)181, (01)00884838085367(21)166, (01)00884838085367(21)408, (01)00884838085367(21)415, (01)00884838085367(21)141, (01)00884838085367(21)365, (01)00884838085367(21)471, (01)00884838085367(21)240, (01)00884838085367(21)450, (01)00884838085367(21)516, (01)00884838085367(21)198, (01)00884838085367(21)228, (01)00884838085367(21)380, (01)00884838085367(21)420, (01)00884838085367(21)397, (01)00884838085367(21)212, (01)00884838085367(21)475, (01)00884838085367(21)269, (01)00884838085367(21)414, (01)00884838085367(21)268, (01)00884838085367(21)74, (01)00884838085367(21)115, (01)00884838085367(21)349, (01)00884838085367(21)291, (01)00884838085367(21)519, (01)00884838085367(21)234, (01)00884838085367(21)219, (01)00884838085367(21)195, (01)00884838085367(21)60, (01)00884838085367(21)549, (01)00884838085367(21)46, (01)00884838085367(21)96, (01)00884838085367(21)416, (01)00884838085367(21)249, (01)00884838085367(21)426, (01)00884838085367(21)162, (01)00884838085367(21)290, (01)00884838085367(21)346, (01)00884838085367(21)49, (01)00884838085367(21)326, (01)00884838085367(21)286, (01)00884838085367(21)125, (01)00884838085367(21)102, (01)00884838085367(21)124, (01)00884838085367(21)138, (01)00884838085367(21)362, (01)00884838085367(21)127, (01)00884838085367(21)145, (01)00884838085367(21)299, (01)00884838085367(21)317, (01)00884838085367(21)187, (01)00884838085367(21)183, (01)00884838085367(21)45, (01)00884838085367(21)331, (01)00884838085367(21)106, (01)00884838085367(21)465, (01)00884838085367(21)112, (01)00884838085367(21)501, (01)00884838085367(21)393, (01)00884838085367(21)116, (01)00884838085367(21)273, (01)00884838085367(21)188, (01)00884838085367(21)264, (01)00884838085367(21)139, (01)00884838085367(21)503, (01)00884838085367(21)122, (01)00884838085367(21)439, (01)00884838085367(21)135, (01)00884838085367(21)248, (01)00884838085367(21)404, (01)00884838085367(21)390, (01)00884838085367(21)263, (01)00884838085367(21)90, (01)00884838085367(21)300, (01)00884838085367(21)224, (01)00884838085367(21)67, (01)00884838085367(21)61, (01)00884838085367(21)157, (01)00884838085367(21)154, (01)00884838085367(21)100, (01)00884838085367(21)217, (01)00884838085367(21)253, (01)00884838085367(21)391, (01)00884838085367(21)144, (01)00884838085367(21)379, (01)00884838085367(21)202, (01)00884838085367(21)105, (01)00884838085367(21)226, (01)00884838085367(21)315, (01)00884838085367(21)464, (01)00884838085367(21)197, (01)00884838085367(21)63, (01)00884838085367(21)252, (01)00884838085367(21)175, (01)00884838085367(21)274, (01)00884838085367(21)163, (01)00884838085367(21)186, (01)00884838085367(21)260, (01)00884838085367(21)502, (01)00884838085367(21)152, (01)00884838085367(21)498, (01)00884838085367(21)156, (01)00884838085367(21)296, (01)00884838085367(21)208, (01)00884838085367(21)430, (01)00884838085367(21)161, (01)00884838085367(21)436, (01)00884838085367(21)409, (01)00884838085367(21)155, (01)00884838085367(21)298, (01)00884838085367(21)191, (01)00884838085367(21)278, (01)00884838085367(21)368, (01)00884838085367(21)94, (01)00884838085367(21)66, (01)00884838085367(21)108, (01)00884838085367(21)200, (01)00884838085367(21)201, (01)00884838085367(21)98, (01)00884838085367(21)189, (01)00884838085367(21)311, (01)00884838085367(21)367, (01)00884838085367(21)297, (01)00884838085367(21)132, (01)00884838085367(21)507, (01)00884838085367(21)451,
10. Azurion 7 B20; Model: 722226; UDI: (01)00884838099272(21)108, (01)00884838099272(21)117, (01)00884838099272(21)78, (01)00884838099272(21)11, (01)00884838099272(21)59, (01)00884838099272(21)75, (01)00884838099272(21)19, (01)00884838099272(21)141, (01)00884838099272(21)21, (01)00884838099272(21)60, (01)00884838099272(21)61, (01)00884838099272(21)10, (01)00884838099272(21)142, (01)00884838099272(21)99, (01)00884838099272(21)36, (01)00884838099272(21)5, (01)00884838099272(21)14, (01)00884838099272(21)45, (01)00884838099272(21)97, (01)00884838099272(21)18, (01)00884838099272(21)47, (01)00884838099272(21)1, (01)00884838099272(21)194, (01)00884838099272(21)29, (01)00884838099272(21)50, (01)00884838099272(21)16, (01)00884838099272(21)82, (01)00884838099272(21)55, (01)00884838099272(21)6, (01)00884838099272(21)7, (01)00884838099272(21)53, (01)00884838099272(21)52, (01)00884838099272(21)63, (01)00884838099272(21)26, (01)00884838099272(21)69, (01)00884838099272(21)42, (01)00884838099272(21)115, (01)00884838099272(21)43, (01)00884838099272(21)73, (01)00884838099272(21)70, (01)00884838099272(21)128, (01)00884838099272(21)40, (01)00884838099272(21)137, (01)00884838099272(21)110, (01)00884838099272(21)68, (01)00884838099272(21)64, (01)00884838099272(21)49, (01)00884838099272(21)38, (01)00884838099272(21)33, (01)00884838099272(21)30, (01)00884838099272(21)92, (01)00884838099272(21)62, (01)00884838099272(21)34, (01)00884838099272(21)71, (01)00884838099272(21)91, (01)00884838099272(21)35, (01)00884838099272(21)31, (01)00884838099272(21)56, (01)00884838099272(21)28, (01)00884838099272(21)79, (01)00884838099272(21)77;
11. Azurion 7 M12; Model: 722078; UDI: (01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)753, (01)00884838085251(21)523, (01)00884838085251(21)293, (01)00884838085251(21)840, (01)00884838085251(21)291, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085251(21)870, (01)00884838085251(21)613, (01)00884838085251(21)598, (01)00884838085251(21)679, (01)00884838085251(21)224, (01)00884838085251(21)829, (01)00884838085251(21)249, (01)00884838085251(21)546, (01)00884838085251(21)478, (01)00884838085251(21)479, (01)00884838085251(21)513, (01)00884838085251(21)278, (01)00884838085251(21)437, (01)00884838085251(21)438, (01)00884838085251(21)456, (01)00884838085251(21)833, (01)00884838085251(21)566, (01)00884838085251(21)488, (01)00884838085251(21)550, (01)00884838085251(21)327, (01)00884838085251(21)571, (01)00884838085251(21)545, (01)00884838085251(21)544, (01)00884838085251(21)465, (01)00884838085251(21)376, (01)00884838085251(21)31, (01)00884838085251(21)921, (01)00884838085251(21)700, (01)00884838085251(21)165, (01)00884838085251(21)445, (01)00884838085251(21)539, (01)00884838085251(21)657, (01)00884838085251(21)656, (01)00884838085251(21)658, (01)00884838085251(21)654, (01)00884838085251(21)436, (01)00884838085251(21)862, (01)00884838085251(21)786, (01)00884838085251(21)308, (01)00884838085251(21)396, (01)00884838085251(21)576, (01)00884838085251(21)121, (01)00884838085251(21)239, (01)00884838085251(21)383, (01)00884838085251(21)491, (01)00884838085251(21)125, (01)00884838085251(21)500, (01)00884838085251(21)645, (01)00884838085251(21)379, (01)00884838085251(21)399, (01)00884838085251(21)803, (01)00884838085251(21)415, (01)00884838085251(21)296, (01)00884838085251(21)136, (01)00884838085251(21)890, (01)00884838085251(21)697, (01)00884838085251(21)626, (01)00884838085251(21)559, (01)00884838085251(21)532, (01)00884838085251(21)538, (01)00884838085251(21)166, (01)00884838085251(21)258, (01)00884838085251(21)257, (01)00884838085251(21)359, (01)00884838085251(21)661, (01)00884838085251(21)824, (01)00884838085251(21)649, (01)00884838085251(21)493, (01)00884838085251(21)720, (01)00884838085251(21)402, (01)00884838085251(21)557, (01)00884838085251(21)556, (01)00884838085251(21)521, (01)00884838085251(21)520, (01)00884838085251(21)558, (01)00884838085251(21)187, (01)00884838085251(21)902, (01)00884838085251(21)269, (01)00884838085251(21)317, (01)00884838085251(21)522, (01)00884838085251(21)611, (01)00884838085251(21)709, (01)00884838085251(21)677, (01)00884838085251(21)535, (01)00884838085251(21)170, (01)00884838085251(21)723, (01)00884838085251(21)251, (01)00884838085251(21)298, (01)00884838085251(21)22, (01)00884838085251(21)305, (01)00884838085251(21)728, (01)00884838085251(21)725, (01)00884838085251(21)524, (01)00884838085251(21)290, (01)00884838085251(21)441, (01)00884838085251(21)384, (01)00884838085251(21)480, (01)00884838085251(21)481, (01)00884838085251(21)360, (01)00884838085251(21)364, (01)00884838085251(21)906, (01)00884838085251(21)294, (01)00884838085251(21)240, (01)00884838085251(21)256, (01)00884838085251(21)603, (01)00884838085251(21)289, (01)00884838085251(21)719, (01)00884838085251(21)163, (01)00884838085251(21)215, (01)00884838085251(21)271, (01)00884838085251(21)788, (01)00884838085251(21)412, (01)00884838085251(21)627, (01)00884838085251(21)644, (01)00884838085251(21)141, (01)00884838085251(21)279, (01)00884838085251(21)876, (01)00884838085251(21)844, (01)00884838085251(21)292, (01)00884838085251(21)748, (01)00884838085251(21)483, (01)00884838085251(21)497, (01)00884838085251(21)309, (01)00884838085251(21)425, (01)00884838085251(21)635, (01)00884838085251(21)232, (01)00884838085251(21)612, (01)00884838085251(21)797, (01)00884838085251(21)247, (01)00884838085251(21)733, (01)00884838085251(21)162, (01)00884838085251(21)517, (01)00884838085251(21)888, (01)00884838085251(21)923, (01)00884838085251(21)205, (01)00884838085251(21)204, (01)00884838085251(21)206, (01)00884838085251(21)197, (01)00884838085251(21)195, (01)00884838085251(21)218, (01)00884838085251(21)444, (01)00884838085251(21)561, (01)00884838085251(21)503, (01)00884838085251(21)689, (01)00884838085251(21)499, (01)00884838085251(21)135, (01)00884838085251(21)589, (01)00884838085251(21)38, (01)00884838085251(21)977, (01)00884838085251(21)738, (01)00884838085251(21)476, (01)00884838085251(21)380, (01)00884838085251(21)453, (01)00884838085251(21)24, (01)00884838085251(21)690, (01)00884838085251(21)356, (01)00884838085251(21)343, (01)00884838085251(21)344, (01)00884838085251(21)174, (01)00884838085251(21)898, (01)00884838085251(21)482, (01)00884838085251(21)378, (01)00884838085251(21)764, (01)00884838085251(21)693, (01)00884838085251(21)694, (01)00884838085251(21)773, (01)00884838085251(21)771, (01)00884838085251(21)772, (01)00884838085251(21)770, (01)00884838085251(21)439, (01)00884838085251(21)191, (01)00884838085251(21)938, (01)00884838085251(21)981, (01)00884838085251(21)982, (01)00884838085251(21)980, (01)00884838085251(21)307, (01)00884838085251(21)628, (01)00884838085251(21)265, (01)00884838085251(21)139, (01)00884838085251(21)511, (01)00884838085251(21)746, (01)00884838085251(21)266, (01)00884838085251(21)264, (01)00884838085251(21)178, (01)00884838085251(21)526, (01)00884838085251(21)179, (01)00884838085251(21)287, (01)00884838085251(21)362, (01)00884838085251(21)361, (01)00884838085251(21)348, (01)00884838085251(21)897, (01)00884838085251(21)845, (01)00884838085251(21)960, (01)00884838085251(21)374, (01)00884838085251(21)375, (01)00884838085251(21)564, (01)00884838085251(21)142, (01)00884838085251(21)469, (01)00884838085251(21)934, (01)00884838085251(21)565, (01)00884838085251(21)929, (01)00884838085251(21)836, (01)00884838085251(21)975, (01)00884838085251(21)835, (01)00884838085251(21)681, (01)00884838085251(21)893, (01)00884838085251(21)382, (01)00884838085251(21)324, (01)00884838085251(21)604, (01)00884838085251(21)713, (01)00884838085251(21)114, (01)00884838085251(21)849, (01)00884838085251(21)346, (01)00884838085251(21)347, (01)00884838085251(21)26, (01)00884838085251(21)621, (01)00884838085251(21)553, (01)00884838085251(21)325, (01)00884838085251(21)648, (01)00884838085251(21)339, (01)00884838085251(21)340, (01)00884838085251(21)414, (01)00884838085251(21)237, (01)00884838085251(21)958, (01)00884838085251(21)751, (01)00884838085251(21)881, (01)00884838085251(21)698, (01)00884838085251(21)610, (01)00884838085251(21)20, (01)00884838085251(21)846, (01)00884838085251(21)625, (01)00884838085251(21)424, (01)00884838085251(21)800, (01)00884838085251(21)838, (01)00884838085251(21)590, (01)00884838085251(21)150, (01)00884838085251(21)762, (01)00884838085251(21)485, (01)00884838085251(21)727, (01)00884838085251(21)847, (01)00884838085251(21)962, (01)00884838085251(21)865, (01)00884838085251(21)371, (01)00884838085251(21)769, (01)00884838085251(21)570, (01)00884838085251(21)572, (01)00884838085251(21)792, (01)00884838085251(21)702, (01)00884838085251(21)196, (01)00884838085251(21)683, (01)00884838085251(21)541, (01)00884838085251(21)213, (01)00884838085251(21)320, (01)00884838085251(21)651, (01)00884838085251(21)722, (01)00884838085251(21)36, (01)00884838085251(21)242, (01)00884838085251(21)431, (01)00884838085251(21)672, (01)00884838085251(21)177, (01)00884838085251(21)578, (01)00884838085251(21)912, (01)00884838085251(21)355, (01)00884838085251(21)504, (01)00884838085251(21)699, (01)00884838085251(21)270, (01)00884838085251(21)306, (01)00884838085251(21)190, (01)00884838085251(21)52, (01)00884838085251(21)366, (01)00884838085251(21)398, (01)00884838085251(21)562, (01)00884838085251(21)470, (01)00884838085251(21)489, (01)00884838085251(21)147, (01)00884838085251(21)160, (01)00884838085251(21)743, (01)00884838085251(21)152, (01)00884838085251(21)759, (01)00884838085251(21)630, (01)00884838085251(21)729, (01)00884838085251(21)151, (01)00884838085251(21)334, (01)00884838085251(21)815, 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(01)00884838085251(21)805, (01)00884838085251(21)686, (01)00884838085251(21)397, (01)00884838085251(21)127, (01)00884838085251(21)128, (01)00884838085251(21)253, (01)00884838085251(21)594, (01)00884838085251(21)301, (01)00884838085251(21)300, (01)00884838085251(21)332, (01)00884838085251(21)35, (01)00884838085251(21)321, (01)00884838085251(21)341, (01)00884838085251(21)563, (01)00884838085251(21)316, (01)00884838085251(21)314, (01)00884838085251(21)496, (01)00884838085251(21)641, (01)00884838085251(21)30, (01)00884838085251(21)950, (01)00884838085251(21)331, (01)00884838085251(21)652, (01)00884838085251(21)349, (01)00884838085251(21)236, (01)00884838085251(21)979, (01)00884838085251(21)831, (01)00884838085251(21)501, (01)00884838085251(21)841, (01)00884838085251(21)682, (01)00884838085251(21)843, (01)00884838085251(21)830, (01)00884838085251(21)323, (01)00884838085251(21)315, (01)00884838085251(21)680, (01)00884838085251(21)365, (01)00884838085251(21)311, (01)00884838085251(21)312, 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(01)00884838085251(21)463, (01)00884838085251(21)461, (01)00884838085251(21)554, (01)00884838085251(21)423, (01)00884838085251(21)252, (01)00884838085251(21)426, (01)00884838085251(21)169, (01)00884838085251(21)650, (01)00884838085251(21)351, (01)00884838085251(21)442, (01)00884838085251(21)968, (01)00884838085251(21)210, (01)00884838085251(21)207, (01)00884838085251(21)208, (01)00884838085251(21)209, (01)00884838085251(21)211, (01)00884838085251(21)623, (01)00884838085251(21)622, (01)00884838085251(21)629, (01)00884838085251(21)129, (01)00884838085251(21)529, (01)00884838085251(21)144, (01)00884838085251(21)750, (01)00884838085251(21)400, (01)00884838085251(21)401, (01)00884838085251(21)411, (01)00884838085251(21)259, (01)00884838085251(21)457, (01)00884838085251(21)926, (01)00884838085251(21)597, (01)00884838085251(21)899, (01)00884838085251(21)322, (01)00884838085251(21)173, (01)00884838085251(21)418, (01)00884838085251(21)637, (01)00884838085251(21)670, (01)00884838085251(21)909, (01)00884838085251(21)601, (01)00884838085251(21)37, (01)00884838085251(21)227, (01)00884838085251(21)984, (01)00884838085251(21)907, (01)00884838085251(21)875, (01)00884838085251(21)717, (01)00884838085251(21)716, (01)00884838085251(21)947, (01)00884838085251(21)945, (01)00884838085251(21)942, (01)00884838085251(21)948, (01)00884838085251(21)940, (01)00884838085251(21)946, (01)00884838085251(21)701, (01)00884838085251(21)620, (01)00884838085251(21)798, (01)00884838085251(21)856, (01)00884838085251(21)710, (01)00884838085251(21)1000, (01)00884838085251(21)663, (01)00884838085251(21)965, (01)00884838085251(21)964, (01)00884838085251(21)736, (01)00884838085251(21)735, (01)00884838085251(21)820, (01)00884838085251(21)819, (01)00884838085251(21)272, (01)00884838085251(21)712, (01)00884838085251(21)714, (01)00884838085251(21)732, (01)00884838085251(21)774, (01)00884838085251(21)381, (01)00884838085251(21)233, (01)00884838085251(21)638, (01)00884838085251(21)318, (01)00884838085251(21)593, (01)00884838085251(21)624, (01)00884838085251(21)776, (01)00884838085251(21)775, (01)00884838085251(21)21, (01)00884838085251(21)267, (01)00884838085251(21)268, (01)00884838085251(21)487, (01)00884838085251(21)421, (01)00884838085251(21)760, (01)00884838085251(21)542, (01)00884838085251(21)614, (01)00884838085251(21)864, (01)00884838085251(21)148, (01)00884838085251(21)837, (01)00884838085251(21)458, (01)00884838085251(21)596, (01)00884838085251(21)377, (01)00884838085251(21)281, (01)00884838085251(21)659, (01)00884838085251(21)784, (01)00884838085251(21)528, (01)00884838085251(21)44, (01)00884838085251(21)42, (01)00884838085251(21)45, (01)00884838085251(21)43, (01)00884838085251(21)41, (01)00884838085251(21)466, (01)00884838085251(21)704, (01)00884838085251(21)219, (01)00884838085251(21)28, (01)00884838085251(21)29, (01)00884838085251(21)217, (01)00884838085251(21)260, (01)00884838085251(21)103, (01)00884838085251(21)430, (01)00884838085251(21)342, (01)00884838085251(21)126, (01)00884838085251(21)184, (01)00884838085251(21)778, (01)00884838085251(21)547, (01)00884838085251(21)586, (01)00884838085251(21)879, (01)00884838085251(21)159, (01)00884838085251(21)363, (01)00884838085251(21)896, (01)00884838085251(21)642, (01)00884838085251(21)472, (01)00884838085251(21)39, (01)00884838085251(21)172, (01)00884838085251(21)961, (01)00884838085251(21)33, (01)00884838085251(21)643, (01)00884838085251(21)581, (01)00884838085251(21)552, (01)00884838085251(21)525, (01)00884838085251(21)857, (01)00884838085251(21)731, (01)00884838085251(21)433, (01)00884838085251(21)432, (01)00884838085251(21)636, (01)00884838085251(21)954, (01)00884838085251(21)447, (01)00884838085251(21)333, (01)00884838085251(21)358, (01)00884838085251(21)540, (01)00884838085251(21)619, (01)00884838085251(21)492, (01)00884838085251(21)527, (01)00884838085251(21)600, (01)00884838085251(21)816, (01)00884838085251(21)434, (01)00884838085251(21)892, (01)00884838085251(21)124, (01)00884838085251(21)122, (01)00884838085251(21)146, (01)00884838085251(21)201, (01)00884838085251(21)509, (01)00884838085251(21)495, (01)00884838085251(21)515, (01)00884838085251(21)353, (01)00884838085251(21)303, (01)00884838085251(21)304, (01)00884838085251(21)186, (01)00884838085251(21)286, (01)00884838085251(21)548, (01)00884838085251(21)518, (01)00884838085251(21)486, (01)00884838085251(21)474, (01)00884838085251(21)475, (01)00884838085251(21)853, (01)00884838085251(21)180, (01)00884838085251(21)243, (01)00884838085251(21)244, (01)00884838085251(21)335, (01)00884838085251(21)549, (01)00884838085251(21)46, (01)00884838085251(21)616, (01)00884838085251(21)972, (01)00884838085251(21)533, (01)00884838085251(21)182, (01)00884838085251(21)850, (01)00884838085251(21)696, (01)00884838085251(21)345, (01)00884838085251(21)939, (01)00884838085251(21)869, (01)00884838085251(21)874, (01)00884838085251(21)871, (01)00884838085251(21)18, (01)00884838085251(21)551, (01)00884838085251(21)917, (01)00884838085251(21)543, (01)00884838085251(21)516, (01)00884838085251(21)12, (01)00884838085251(21)416, (01)00884838085251(21)155, (01)00884838085251(21)446, (01)00884838085251(21)685, (01)00884838085251(21)715, (01)00884838085251(21)225, (01)00884838085251(21)913, (01)00884838085251(21)582, (01)00884838085251(21)908, (01)00884838085251(21)19, (01)00884838085251(21)435, (01)00884838085251(21)16, (01)00884838085251(21)11, (01)00884838085251(21)664, (01)00884838085251(21)901, (01)00884838085251(21)508, (01)00884838085251(21)530, (01)00884838085251(21)198;
12. Azurion 7 M12; Model: 722223; UDI: (01)00884838099241(21)189, (01)00884838099241(21)47, (01)00884838099241(21)77, (01)00884838099241(21)36, (01)00884838099241(21)37, (01)00884838099241(21)87, (01)00884838099241(21)69, (01)00884838099241(21)67, (01)00884838099241(21)52, (01)00884838099241(21)127, (01)00884838099241(21)104, (01)00884838099241(21)96, (01)00884838099241(21)130, (01)00884838099241(21)89, (01)00884838099241(21)119, (01)00884838099241(21)99, (01)00884838099241(21)100, (01)00884838099241(21)155, (01)00884838099241(21)18, (01)00884838099241(21)17, (01)00884838099241(21)46, (01)00884838099241(21)132, (01)00884838099241(21)10, (01)00884838099241(21)134, (01)00884838099241(21)7, (01)00884838099241(21)25, (01)00884838099241(21)106, (01)00884838099241(21)78, (01)00884838099241(21)40, (01)00884838099241(21)9, (01)00884838099241(21)8, (01)00884838099241(21)157, (01)00884838099241(21)64, (01)00884838099241(21)28, (01)00884838099241(21)111, (01)00884838099241(21)35, (01)00884838099241(21)65, (01)00884838099241(21)68, (01)00884838099241(21)61, (01)00884838099241(21)43, (01)00884838099241(21)21, (01)00884838099241(21)76, (01)00884838099241(21)48, (01)00884838099241(21)12, (01)00884838099241(21)30, (01)00884838099241(21)22, (01)00884838099241(21)26, (01)00884838099241(21)176, (01)00884838099241(21)91, (01)00884838099241(21)115, (01)00884838099241(21)170, (01)00884838099241(21)92, (01)00884838099241(21)41, (01)00884838099241(21)80, (01)00884838099241(21)74, (01)00884838099241(21)72, (01)00884838099241(21)24, (01)00884838099241(21)38, (01)00884838099241(21)34, (01)00884838099241(21)27, (01)00884838099241(21)83, (01)00884838099241(21)86, (01)00884838099241(21)33, (01)00884838099241(21)13, (01)00884838099241(21)107;
13. Azurion 7 M20; Model: 722079; UDI: (01)00884838085268(21)1023, (01)00884838085268(21)646, (01)00884838085268(21)645, (01)00884838085268(21)1013, (01)00884838085268(21)1387, (01)00884838085268(21)460, (01)00884838085268(21)35, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)703307, (01)00884838085268(21)1048, (01)00884838085268(21)1137, (01)00884838085268(21)401, (01)00884838085268(21)1010, (01)00884838085268(21)266, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)1054, (01)00884838085268(21)536, (01)00884838085268(21)818, (01)00884838085268(21)412, (01)00884838085268(21)617, (01)00884838085268(21)488, (01)00884838085268(21)53, (01)00884838085268(21)57, (01)00884838085268(21)905, (01)00884838085268(21)55, (01)00884838085268(21)992.(01)00884838085268(21)691, (01)00884838085268(21)848, (01)00884838085268(21)809, (01)00884838085268(21)1033, (01)00884838085268(21)836, (01)00884838085268(21)891, (01)00884838085268(21)1155, (01)00884838085268(21)466, (01)00884838085268(21)1157, (01)00884838085268(21)703559, (01)00884838085268(21)263, (01)00884838085268(21)703391, (01)00884838085268(21)420, (01)00884838085268(21)673, (01)00884838085268(21)297, (01)00884838085268(21)298, (01)00884838085268(21)299, (01)00884838085268(21)564, (01)00884838085268(21)838, (01)00884838085268(21)1032, (01)00884838085268(21)1117, (01)00884838085268(21)987, (01)00884838085268(21)1310, (01)00884838085268(21)47, (01)00884838085268(21)1365, (01)00884838085268(21)1408, (01)00884838085268(21)881, (01)00884838085268(21)774, (01)00884838085268(21)856, (01)00884838085268(21)922, (01)00884838085268(21)58, (01)00884838085268(21)471, (01)00884838085268(21)1012, (01)00884838085268(21)755, (01)00884838085268(21)633, (01)00884838085268(21)703540, (01)00884838085268(21)296, (01)00884838085268(21)703558, (01)00884838085268(21)991, (01)00884838085268(21)574, (01)00884838085268(21)703336, (01)00884838085268(21)842, (01)00884838085268(21)884, (01)00884838085268(21)753, (01)00884838085268(21)703493, (01)00884838085268(21)790, (01)00884838085268(21)1086, (01)00884838085268(21)840, (01)00884838085268(21)481, (01)00884838085268(21)408, (01)00884838085268(21)407, (01)00884838085268(21)703350, (01)00884838085268(21)877, (01)00884838085268(21)703395, (01)00884838085268(21)703323, (01)00884838085268(21)590, (01)00884838085268(21)710, (01)00884838085268(21)716, (01)00884838085268(21)711, (01)00884838085268(21)713, (01)00884838085268(21)709, (01)00884838085268(21)1216, (01)00884838085268(21)483, (01)00884838085268(21)1098, (01)00884838085268(21)1392, (01)00884838085268(21)241, (01)00884838085268(21)703408, (01)00884838085268(21)1363, (01)00884838085268(21)1108, (01)00884838085268(21)1414, (01)00884838085268(21)703404, (01)00884838085268(21)1355, (01)00884838085268(21)703387, (01)00884838085268(21)863, (01)00884838085268(21)350, (01)00884838085268(21)528, (01)00884838085268(21)908, (01)00884838085268(21)1238, (01)00884838085268(21)262, (01)00884838085268(21)598, (01)00884838085268(21)859, (01)00884838085268(21)858, (01)00884838085268(21)275, (01)00884838085268(21)520, (01)00884838085268(21)335, (01)00884838085268(21)593, (01)00884838085268(21)1018, (01)00884838085268(21)911, (01)00884838085268(21)480, (01)00884838085268(21)703329, (01)00884838085268(21)1410, (01)00884838085268(21)213, (01)00884838085268(21)325, (01)00884838085268(21)887, (01)00884838085268(21)903, (01)00884838085268(21)496, (01)00884838085268(21)703413, (01)00884838085268(21)1432, (01)00884838085268(21)594, (01)00884838085268(21)1312, (01)00884838085268(21)1309, (01)00884838085268(21)999, (01)00884838085268(21)1424, (01)00884838085268(21)465, (01)00884838085268(21)674, (01)00884838085268(21)1084, (01)00884838085268(21)353, (01)00884838085268(21)1230, (01)00884838085268(21)813, (01)00884838085268(21)703508, (01)00884838085268(21)33, (01)00884838085268(21)1346, (01)00884838085268(21)1189, (01)00884838085268(21)361, 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(01)00884838085268(21)703354, (01)00884838085268(21)1180, (01)00884838085268(21)1067, (01)00884838085268(21)723, (01)00884838085268(21)1159, (01)00884838085268(21)703570, (01)00884838085268(21)703454, (01)00884838085268(21)1173, (01)00884838085268(21)703422, (01)00884838085268(21)703518, (01)00884838085268(21)1404, (01)00884838085268(21)1437, (01)00884838085268(21)1092, (01)00884838085268(21)703484, (01)00884838085268(21)1085, (01)00884838085268(21)703325, (01)00884838085268(21)568, (01)00884838085268(21)703403, (01)00884838085268(21)1068, (01)00884838085268(21)1099, (01)00884838085268(21)703519, (01)00884838085268(21)1126, (01)00884838085268(21)703437, (01)00884838085268(21)703451, (01)00884838085268(21)1071, (01)00884838085268(21)1307, (01)00884838085268(21)612, (01)00884838085268(21)703373, (01)00884838085268(21)277, (01)00884838085268(21)917, (01)00884838085268(21)225, (01)00884838085268(21)256, (01)00884838085268(21)1079, (01)00884838085268(21)918, (01)00884838085268(21)703365, (01)00884838085268(21)983, (01)00884838085268(21)636, (01)00884838085268(21)614, (01)00884838085268(21)640.(01)00884838085268(21)864, (01)00884838085268(21)1407, (01)00884838085268(21)288, (01)00884838085268(21)1303, (01)00884838085268(21)1304, (01)00884838085268(21)1302, (01)00884838085268(21)1130, (01)00884838085268(21)1313, (01)00884838085268(21)647, (01)00884838085268(21)1383, (01)00884838085268(21)794, (01)00884838085268(21)651, (01)00884838085268(21)692, (01)00884838085268(21)703357, (01)00884838085268(21)487, (01)00884838085268(21)703363, (01)00884838085268(21)500, (01)00884838085268(21)980, (01)00884838085268(21)703452, (01)00884838085268(21)463, (01)00884838085268(21)26, (01)00884838085268(21)541, (01)00884838085268(21)893, (01)00884838085268(21)1145, (01)00884838085268(21)373, (01)00884838085268(21)294, (01)00884838085268(21)635, (01)00884838085268(21)768, (01)00884838085268(21)929, (01)00884838085268(21)609,
14. Azurion 7 M20; Model: 722224; UDI: (01)00884838099258(21)260, (01)00884838099258(21)246, (01)00884838099258(21)90, (01)00884838099258(21)91, (01)00884838099258(21)43, (01)00884838099258(21)82, (01)00884838099258(21)40, (01)00884838099258(21)110, (01)00884838099258(21)164, (01)00884838099258(21)224, (01)00884838099258(21)190, (01)00884838099258(21)153, (01)00884838099258(21)79, (01)00884838099258(21)75, (01)00884838099258(21)218, (01)00884838099258(21)216, (01)00884838099258(21)191, (01)00884838099258(21)42, (01)00884838099258(21)166, (01)00884838099258(21)56, (01)00884838099258(21)105, (01)00884838099258(21)240, (01)00884838099258(21)94, (01)00884838099258(21)33, (01)00884838099258(21)41, (01)00884838099258(21)129, (01)00884838099258(21)151, (01)00884838099258(21)49, (01)00884838099258(21)154, (01)00884838099258(21)217, (01)00884838099258(21)192, (01)00884838099258(21)108, (01)00884838099258(21)47, (01)00884838099258(21)119, (01)00884838099258(21)112, (01)00884838099258(21)134, (01)00884838099258(21)148, (01)00884838099258(21)78, (01)00884838099258(21)45, (01)00884838099258(21)100, (01)00884838099258(21)125, (01)00884838099258(21)124, (01)00884838099258(21)183, (01)00884838099258(21)39, (01)00884838099258(21)88, (01)00884838099258(21)101, (01)00884838099258(21)99, (01)00884838099258(21)106, (01)00884838099258(21)36, (01)00884838099258(21)72, (01)00884838099258(21)141, (01)00884838099258(21)28, (01)00884838099258(21)46, (01)00884838099258(21)113, (01)00884838099258(21)194, (01)00884838099258(21)102, (01)00884838099258(21)139, (01)00884838099258(21)253, (01)00884838099258(21)64, (01)00884838099258(21)84, (01)00884838099258(21)174, (01)00884838099258(21)76, (01)00884838099258(21)109, (01)00884838099258(21)160, (01)00884838099258(21)34, (01)00884838099258(21)220, (01)00884838099258(21)185, (01)00884838099258(21)196, (01)00884838099258(21)258, (01)00884838099258(21)353, (01)00884838099258(21)257, (01)00884838099258(21)334, (01)00884838099258(21)63, (01)00884838099258(21)149, (01)00884838099258(21)167, (01)00884838099258(21)87, (01)00884838099258(21)9, (01)00884838099258(21)57, (01)00884838099258(21)62, (01)00884838099258(21)37, (01)00884838099258(21)65, (01)00884838099258(21)30, (01)00884838099258(21)127, (01)00884838099258(21)386, (01)00884838099258(21)256, (01)00884838099258(21)24, (01)00884838099258(21)13, (01)00884838099258(21)93, (01)00884838099258(21)171, (01)00884838099258(21)48, (01)00884838099258(21)98, (01)00884838099258(21)77, (01)00884838099258(21)145, (01)00884838099258(21)81, (01)00884838099258(21)8, (01)00884838099258(21)248, (01)00884838099258(21)31, (01)00884838099258(21)358, (01)00884838099258(21)175, (01)00884838099258(21)7, (01)00884838099258(21)133, (01)00884838099258(21)186, (01)00884838099258(21)19, (01)00884838099258(21)6, (01)00884838099258(21)32, (01)00884838099258(21)200, (01)00884838099258(21)20, (01)00884838099258(21)223, (01)00884838099258(21)66, (01)00884838099258(21)67, (01)00884838099258(21)198, (01)00884838099258(21)85, (01)00884838099258(21)59, (01)00884838099258(21)156, (01)00884838099258(21)347, (01)00884838099258(21)270, (01)00884838099258(21)52, (01)00884838099258(21)29, (01)00884838099258(21)71, (01)00884838099258(21)209, (01)00884838099258(21)11, (01)00884838099258(21)132, (01)00884838099258(21)74, (01)00884838099258(21)68, (01)00884838099258(21)243, (01)00884838099258(21)180, (01)00884838099258(21)97, (01)00884838099258(21)203, (01)00884838099258(21)241, (01)00884838099258(21)92, (01)00884838099258(21)51, (01)00884838099258(21)70, (01)00884838099258(21)168, (01)00884838099258(21)61, (01)00884838099258(21)142, (01)00884838099258(21)137, (01)00884838099258(21)83, (01)00884838099258(21)118, (01)00884838099258(21)144; |
| FEI Number |
3042175844
|
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 6
Best Netherlands
|
Manufacturer Reason
for Recall | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in
performance as they age, particularly beyond six years of service. Issues with an HDD may, depending
on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality.
Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some
cases, a system restart may temporarily restore functionality. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On April 30, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken:
1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue.
2. In case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available.
3. 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.
4. 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.
5. If you experience the issue described in this letter, please report it to your local Philips
representative.
Actions by Philips:
Philips will replace the HDDs in all affected systems. Philips expects to start replacing the HDDs in September 2026. A local Philips representative will contact you to schedule a visit to replace the HDDs in your system. |
|---|
| Quantity in Commerce | 3069 units (872 US, 2224 OUS) |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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