| | Class 2 Device Recall Philips Azurion systems |  |
| Date Initiated by Firm | April 28, 2026 |
|---|
| Date Posted | May 21, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2225-2026 |
|---|
| Recall Event ID |
98812 |
| 510(K)Number | K172822 K181830 K200917 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers.
1. Azurion 3 M12; Model Numbers: 722063, 722229.
2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230.
3. Azurion 5 M12; Model Numbers: 722227, 722231.
4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281.
5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235.
6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236.
7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233.
8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282. |
|---|
| Code Information |
1. Model Number [UDI]: 722063 [(01)00884838085275(21)77, (01)00884838085275(21)47, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)43, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)97, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)116, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)137, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)78, (01)00884838085275(21)76, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)26, (01)00884838085275(21)106, (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)87, (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)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55]; 722229 [(01)00884838116726(21)7, (01)00884838116726(21)3, (01)00884838116726(21)10, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13].
2. Model Number [UDI]: 722064 [(01)00884838085282(21)513, (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)479, (01)00884838085282(21)190, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)502, (01)00884838085282(21)425, (01)00884838085282(21)89, (01)00884838085282(21)303, (01)00884838085282(21)130, (01)00884838085282(21)157, (01)00884838085282(21)60, (01)00884838085282(21)253, (01)00884838085282(21)280, (01)00884838085282(21)373, (01)00884838085282(21)417, (01)00884838085282(21)277, (01)00884838085282(21)102, (01)00884838085282(21)467, (01)00884838085282(21)461, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)510, (01)00884838085282(21)49, (01)00884838085282(21)246, (01)00884838085282(21)282, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)274, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)329, (01)00884838085282(21)276, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)249, (01)00884838085282(21)156, (01)00884838085282(21)380, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)197, (01)00884838085282(21)289, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)448, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)278, (01)00884838085282(21)55, (01)00884838085282(21)39, (01)00884838085282(21)45, (01)00884838085282(21)66, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)183, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)293, (01)00884838085282(21)379, (01)00884838085282(21)292, (01)00884838085282(21)321, (01)00884838085282(21)151, (01)00884838085282(21)237, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)391, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)79, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)252, (01)00884838085282(21)91, (01)00884838085282(21)73, (01)00884838085282(21)74, (01)00884838085282(21)309, (01)00884838085282(21)400, (01)00884838085282(21)251, (01)00884838085282(21)480, (01)00884838085282(21)387, (01)00884838085282(21)269, (01)00884838085282(21)111, (01)00884838085282(21)11, (01)00884838085282(21)509, (01)00884838085282(21)454, (01)00884838085282(21)478, (01)00884838085282(21)262, (01)00884838085282(21)491, (01)00884838085282(21)337, (01)00884838085282(21)468, (01)00884838085282(21)412, (01)00884838085282(21)414, (01)00884838085282(21)405, (01)00884838085282(21)396, (01)00884838085282(21)247, (01)00884838085282(21)443, (01)00884838085282(21)310, (01)00884838085282(21)406, (01)00884838085282(21)517, (01)00884838085282(21)432, (01)00884838085282(21)504, (01)00884838085282(21)457, (01)00884838085282(21)426, (01)00884838085282(21)304, (01)00884838085282(21)469, (01)00884838085282(21)340, (01)00884838085282(21)393, (01)00884838085282(21)343, (01)00884838085282(21)458, (01)00884838085282(21)322, (01)00884838085282(21)444, (01)00884838085282(21)508, (01)00884838085282(21)445, (01)00884838085282(21)395, (01)00884838085282(21)385, (01)00884838085282(21)505, (01)00884838085282(21)472, (01)00884838085282(21)514, (01)00884838085282(21)333, (01)00884838085282(21)236, (01)00884838085282(21)471, (01)00884838085282(21)401, (01)00884838085282(21)234, (01)00884838085282(21)503, (01)00884838085282(21)394, (01)00884838085282(21)407, (01)00884838085282(21)470, (01)00884838085282(21)498, (01)00884838085282(21)413, (01)00884838085282(21)440, (01)00884838085282(21)463, (01)00884838085282(21)330, (01)00884838085282(21)475, (01)00884838085282(21)473, (01)00884838085282(21)501, (01)00884838085282(21)308, (01)00884838085282(21)225, (01)00884838085282(21)483, (01)00884838085282(21)474, (01)00884838085282(21)344, (01)00884838085282(21)389, (01)00884838085282(21)492, (01)00884838085282(21)324, (01)00884838085282(21)265, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)496, (01)00884838085282(21)427, (01)00884838085282(21)51, (01)00884838085282(21)388, (01)00884838085282(21)177, (01)00884838085282(21)47, (01)00884838085282(21)59, (01)00884838085282(21)167, (01)00884838085282(21)174, (01)00884838085282(21)165, (01)00884838085282(21)452, (01)00884838085282(21)447, (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)378, (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)397, (01)00884838085282(21)500, (01)00884838085282(21)226, (01)00884838085282(21)408, (01)00884838085282(21)381, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)404, (01)00884838085282(21)285, (01)00884838085282(21)515, (01)00884838085282(21)476, (01)00884838085282(21)449, (01)00884838085282(21)477, (01)00884838085282(21)338, (01)00884838085282(21)419, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)434, (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)372, (01)00884838085282(21)188, (01)00884838085282(21)429, (01)00884838085282(21)296, (01)00884838085282(21)172, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)306, (01)00884838085282(21)437, (01)00884838085282(21)210, (01)00884838085282(21)315, (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)166, (01)00884838085282(21)96, (01)00884838085282(21)135]; 722222 [(01)00884838099210(21)101, (01)00884838099210(21)318, (01)00884838099210(21)364, (01)00884838099210(21)146, (01)00884838099210(21)269, (01)00884838099210(21)75, (01)00884838099210(21)246, (01)00884838099210(21)304, (01)00884838099210(21)316, (01)00884838099210(21)338, (01)00884838099210(21)345, (01)00884838099210(21)344, (01)00884838099210(21)343, (01)00884838099210(21)336, (01)00884838099210(21)339, (01)00884838099210(21)346, (01)00884838099210(21)340, (01)00884838099210(21)27, (01)00884838099210(21)312, (01)00884838099210(21)172, (01)00884838099210(21)35, (01)00884838099210(21)151, (01)00884838099210(21)277, (01)00884838099210(21)224, (01)00884838099210(21)102, (01)00884838099210(21)88, (01)00884838099210(21)145, (01)00884838099210(21)89, (01)00884838099210(21)108, (01)00884838099210(21)132, (01)00884838099210(21)48, (01)00884838099210(21)305, (01)00884838099210(21)80, (01)00884838099210(21)83, (01)00884838099210(21)47, (01)00884838099210(21)270, (01)00884838099210(21)21, (01)00884838099210(21)64, (01)00884838099210(21)22, (01)00884838099210(21)22A, (01)00884838099210(21)98, (01)00884838099210(21)29, (01)00884838099210(21)248, (01)00884838099210(21)369, (01)00884838099210(21)389, (01)00884838099210(21)222, (01)00884838099210(21)134, (01)00884838099210(21)266, (01)00884838099210(21)378, (01)00884838099210(21)245, (01)00884838099210(21)24, (01)00884838099210(21)244, (01)00884838099210(21)335, (01)00884838099210(21)177, (01)00884838099210(21)11, (01)00884838099210(21)72, (01)00884838099210(21)50, (01)00884838099210(21)263, (01)00884838099210(21)65, (01)00884838099210(21)278, (01)00884838099210(21)188, (01)00884838099210(21)68, (01)00884838099210(21)51, (01)00884838099210(21)76, (01)00884838099210(21)243, (01)00884838099210(21)31, (01)00884838099210(21)193, (01)00884838099210(21)106, (01)00884838099210(21)268, (01)00884838099210(21)104, (01)00884838099210(21)105, (01)00884838099210(21)252, (01)00884838099210(21)250, (01)00884838099210(21)251, (01)00884838099210(21)253, (01)00884838099210(21)183, (01)00884838099210(21)375, (01)00884838099210(21)311, (01)00884838099210(21)228, (01)00884838099210(21)322, (01)00884838099210(21)189, (01)00884838099210(21)297, (01)00884838099210(21)190, (01)00884838099210(21)313, (01)00884838099210(21)169, (01)00884838099210(21)219, (01)00884838099210(21)247, (01)00884838099210(21)282, (01)00884838099210(21)217, (01)00884838099210(21)143, (01)00884838099210(21)349, (01)00884838099210(21)225, (01)00884838099210(21)162, (01)00884838099210(21)333, (01)00884838099210(21)185, (01)00884838099210(21)166, (01)00884838099210(21)161, (01)00884838099210(21)16, (01)00884838099210(21)370, (01)00884838099210(21)396, (01)00884838099210(21)374, (01)00884838099210(21)249, (01)00884838099210(21)115, (01)00884838099210(21)321, (01)00884838099210(21)211, (01)00884838099210(21)168, (01)00884838099210(21)127, (01)00884838099210(21)261, (01)00884838099210(21)54, (01)00884838099210(21)14, (01)00884838099210(21)38, (01)00884838099210(21)10, (01)00884838099210(21)67, (01)00884838099210(21)165, (01)00884838099210(21)272, (01)00884838099210(21)326, (01)00884838099210(21)173, (01)00884838099210(21)90, (01)00884838099210(21)109, (01)00884838099210(21)291, (01)00884838099210(21)292, (01)00884838099210(21)288, (01)00884838099210(21)290, (01)00884838099210(21)295, (01)00884838099210(21)289, (01)00884838099210(21)294, (01)00884838099210(21)186, (01)00884838099210(21)181, (01)00884838099210(21)107, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)296, (01)00884838099210(21)315, (01)00884838099210(21)314, (01)00884838099210(21)77, (01)00884838099210(21)380, (01)00884838099210(21)110, (01)00884838099210(21)184, (01)00884838099210(21)180, (01)00884838099210(21)131, (01)00884838099210(21)214, (01)00884838099210(21)116, (01)00884838099210(21)276, (01)00884838099210(21)73, (01)00884838099210(21)157, (01)00884838099210(21)87, (01)00884838099210(21)114, (01)00884838099210(21)274, (01)00884838099210(21)135, (01)00884838099210(21)159, (01)00884838099210(21)158, (01)00884838099210(21)78, (01)00884838099210(21)125, (01)00884838099210(21)218, (01)00884838099210(21)124, (01)00884838099210(21)126, (01)00884838099210(21)212]; 722230 [(01)00884838116733(21)20, (01)00884838116733(21)23, (01)00884838116733(21)19, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)39, (01)00884838116733(21)27, (01)00884838116733(21)13, (01)00884838116733(21)12, (01)00884838116733(21)1]; 722280 [(01)00884838103276(21)57, (01)00884838103276(21)161, (01)00884838103276(21)43, (01)00884838103276(21)179, (01)00884838103276(21)229, (01)00884838103276(21)249, (01)00884838103276(21)65, (01)00884838103276(21)76, (01)00884838103276(21)233, (01)00884838103276(21)232, (01)00884838103276(21)113, (01)00884838103276(21)167, (01)00884838103276(21)165, (01)00884838103276(21)80, (01)00884838103276(21)128, (01)00884838103276(21)158, (01)00884838103276(21)149, (01)00884838103276(21)194, (01)00884838103276(21)44, (01)00884838103276(21)100, (01)00884838103276(21)164, (01)00884838103276(21)240, (01)00884838103276(21)246, (01)00884838103276(21)66, (01)00884838103276(21)135, (01)00884838103276(21)175, (01)00884838103276(21)99, (01)00884838103276(21)112, (01)00884838103276(21)34, (01)00884838103276(21)79, (01)00884838103276(21)130, (01)00884838103276(21)48, (01)00884838103276(21)52, (01)00884838103276(21)141, (01)00884838103276(21)131, (01)00884838103276(21)189, (01)00884838103276(21)37, (01)00884838103276(21)83, (01)00884838103276(21)223, (01)00884838103276(21)139, (01)00884838103276(21)87, (01)00884838103276(21)61, (01)00884838103276(21)259, (01)00884838103276(21)218, (01)00884838103276(21)90, (01)00884838103276(21)188, (01)00884838103276(21)105, (01)00884838103276(21)23, (01)00884838103276(21)30, (01)00884838103276(21)132, (01)00884838103276(21)96, (01)00884838103276(21)107, (01)00884838103276(21)171, (01)00884838103276(21)118, (01)00884838103276(21)21, (01)00884838103276(21)174, (01)00884838103276(21)284, (01)00884838103276(21)220, (01)00884838103276(21)147, (01)00884838103276(21)133, (01)00884838103276(21)252, (01)00884838103276(21)38, (01)00884838103276(21)243, (01)00884838103276(21)177, (01)00884838103276(21)178, (01)00884838103276(21)150, (01)00884838103276(21)69, (01)00884838103276(21)148, (01)00884838103276(21)210, (01)00884838103276(21)207, (01)00884838103276(21)98, (01)00884838103276(21)211, (01)00884838103276(21)127, (01)00884838103276(21)222, (01)00884838103276(21)144, (01)00884838103276(21)143, (01)00884838103276(21)142, (01)00884838103276(21)198, (01)00884838103276(21)71, (01)00884838103276(21)146, (01)00884838103276(21)241, (01)00884838103276(21)206, (01)00884838103276(21)152, (01)00884838103276(21)247, (01)00884838103276(21)262, (01)00884838103276(21)279, (01)00884838103276(21)157, (01)00884838103276(21)40, (01)00884838103276(21)17, (01)00884838103276(21)204, (01)00884838103276(21)260, (01)00884838103276(21)275, (01)00884838103276(21)187, (01)00884838103276(21)208, (01)00884838103276(21)46, (01)00884838103276(21)271, (01)00884838103276(21)235, (01)00884838103276(21)234, (01)00884838103276(21)91, (01)00884838103276(21)162, (01)00884838103276(21)97, (01)00884838103276(21)153, (01)00884838103276(21)245, (01)00884838103276(21)106, (01)00884838103276(21)173, (01)00884838103276(21)258, (01)00884838103276(21)120, (01)00884838103276(21)45, (01)00884838103276(21)92, (01)00884838103276(21)226, (01)00884838103276(21)254, (01)00884838103276(21)213, (01)00884838103276(21)224, (01)00884838103276(21)95, (01)00884838103276(21)54, (01)00884838103276(21)126, (01)00884838103276(21)216, (01)00884838103276(21)19, (01)00884838103276(21)215, (01)00884838103276(21)93, (01)00884838103276(21)24, (01)00884838103276(21)129, (01)00884838103276(21)74, (01)00884838103276(21)219, (01)00884838103276(21)88, (01)00884838103276(21)85, (01)00884838103276(21)86, (01)00884838103276(21)170, (01)00884838103276(21)55, (01)00884838103276(21)102, (01)00884838103276(21)124, (01)00884838103276(21)125, (01)00884838103276(21)123, (01)00884838103276(21)151, (01)00884838103276(21)39, (01)00884838103276(21)47, (01)00884838103276(21)101, (01)00884838103276(21)209, (01)00884838103276(21)41, (01)00884838103276(21)42, (01)00884838103276(21)53, (01)00884838103276(21)250, (01)00884838103276(21)239, (01)00884838103276(21)248, (01)00884838103276(21)108, (01)00884838103276(21)119, (01)00884838103276(21)205, (01)00884838103276(21)197, (01)00884838103276(21)82, (01)00884838103276(21)33, (01)00884838103276(21)20, (01)00884838103276(21)231, (01)00884838103276(21)63, (01)00884838103276(21)261, (01)00884838103276(21)138, (01)00884838103276(21)255, (01)00884838103276(21)212, (01)00884838103276(21)84, (01)00884838103276(21)145, (01)00884838103276(21)221, (01)00884838103276(21)36, (01)00884838103276(21)256, (01)00884838103276(21)59, (01)00884838103276(21)196, (01)00884838103276(21)50, (01)00884838103276(21)110, (01)00884838103276(21)272, (01)00884838103276(21)199, (01)00884838103276(21)264, (01)00884838103276(21)140, (01)00884838103276(21)68, (01)00884838103276(21)117, (01)00884838103276(21)49, (01)00884838103276(21)257, (01)00884838103276(21)60, (01)00884838103276(21)103, (01)00884838103276(21)237, (01)00884838103276(21)72, (01)00884838103276(21)160, (01)00884838103276(21)81, (01)00884838103276(21)114, (01)00884838103276(21)137, (01)00884838103276(21)58, (01)00884838103276(21)73, (01)00884838103276(21)35, (01)00884838103276(21)22, (01)00884838103276(21)94].
3. Model Number [UDI]: 722227 [(01)00884838099227(21)159, (01)00884838099227(21)197, (01)00884838099227(21)149, (01)00884838099227(21)54, (01)00884838099227(21)56, (01)00884838099227(21)230, (01)00884838099227(21)98, (01)00884838099227(21)31, (01)00884838099227(21)128, (01)00884838099227(21)81, (01)00884838099227(21)37, (01)00884838099227(21)320, (01)00884838099227(21)53, (01)00884838099227(21)246, (01)00884838099227(21)245, (01)00884838099227(21)84, (01)00884838099227(21)38, (01)00884838099227(21)28, (01)00884838099227(21)29, (01)00884838099227(21)170, (01)00884838099227(21)30, (01)00884838099227(21)108, (01)00884838099227(21)168, (01)00884838099227(21)172, (01)00884838099227(21)62, (01)00884838099227(21)236, (01)00884838099227(21)104, (01)00884838099227(21)59, (01)00884838099227(21)109, (01)00884838099227(21)101, (01)00884838099227(21)99, (01)00884838099227(21)247, (01)00884838099227(21)177, (01)00884838099227(21)138, (01)00884838099227(21)337, (01)00884838099227(21)61, (01)00884838099227(21)287, (01)00884838099227(21)55, (01)00884838099227(21)215, (01)00884838099227(21)216, (01)00884838099227(21)73, (01)00884838099227(21)318, (01)00884838099227(21)167, (01)00884838099227(21)85, (01)00884838099227(21)191, (01)00884838099227(21)20, (01)00884838099227(21)226, (01)00884838099227(21)83, (01)00884838099227(21)218, (01)00884838099227(21)195, (01)00884838099227(21)43, (01)00884838099227(21)18, (01)00884838099227(21)153, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)120, (01)00884838099227(21)204, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)17, (01)00884838099227(21)141, (01)00884838099227(21)103, (01)00884838099227(21)355, (01)00884838099227(21)113, (01)00884838099227(21)315, (01)00884838099227(21)161, (01)00884838099227(21)194, (01)00884838099227(21)105, (01)00884838099227(21)171, (01)00884838099227(21)49, (01)00884838099227(21)71, (01)00884838099227(21)91, (01)00884838099227(21)187, (01)00884838099227(21)166, (01)00884838099227(21)210, (01)00884838099227(21)219, (01)00884838099227(21)222, (01)00884838099227(21)273, (01)00884838099227(21)205, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)80, (01)00884838099227(21)123, (01)00884838099227(21)243, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)22, (01)00884838099227(21)140, (01)00884838099227(21)362, (01)00884838099227(21)242, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)136, (01)00884838099227(21)137, (01)00884838099227(21)89, (01)00884838099227(21)294, (01)00884838099227(21)2, (01)00884838099227(21)111, (01)00884838099227(21)221, (01)00884838099227(21)165, (01)00884838099227(21)1, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)330, (01)00884838099227(21)67, (01)00884838099227(21)260, (01)00884838099227(21)148, (01)00884838099227(21)281, (01)00884838099227(21)248, (01)00884838099227(21)333, (01)00884838099227(21)199, (01)00884838099227(21)183, (01)00884838099227(21)106, (01)00884838099227(21)253, (01)00884838099227(21)52, (01)00884838099227(21)26, (01)00884838099227(21)233, (01)00884838099227(21)301, (01)00884838099227(21)211, (01)00884838099227(21)154, (01)00884838099227(21)217, (01)00884838099227(21)332, (01)00884838099227(21)44, (01)00884838099227(21)198, (01)00884838099227(21)297, (01)00884838099227(21)206, (01)00884838099227(21)292, (01)00884838099227(21)58, (01)00884838099227(21)130, (01)00884838099227(21)203, (01)00884838099227(21)107, (01)00884838099227(21)93, (01)00884838099227(21)125, (01)00884838099227(21)240, (01)00884838099227(21)122, (01)00884838099227(21)118, (01)00884838099227(21)46, (01)00884838099227(21)252, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)202, (01)00884838099227(21)100, (01)00884838099227(21)115, (01)00884838099227(21)133, (01)00884838099227(21)350, (01)00884838099227(21)175, (01)00884838099227(21)229, (01)00884838099227(21)304, (01)00884838099227(21)124, (01)00884838099227(21)220, (01)00884838099227(21)79, (01)00884838099227(21)60, (01)00884838099227(21)311, (01)00884838099227(21)147, (01)00884838099227(21)146, (01)00884838099227(21)319, (01)00884838099227(21)74, (01)00884838099227(21)188, (01)00884838099227(21)9, (01)00884838099227(21)8, (01)00884838099227(21)94, (01)00884838099227(21)82, (01)00884838099227(21)86, (01)00884838099227(21)286, (01)00884838099227(21)96, (01)00884838099227(21)227, (01)00884838099227(21)231, (01)00884838099227(21)126, (01)00884838099227(21)162, (01)00884838099227(21)299, (01)00884838099227(21)35, (01)00884838099227(21)11, (01)00884838099227(21)259, (01)00884838099227(21)180, (01)00884838099227(21)160, (01)00884838099227(21)196, (01)00884838099227(21)208, (01)00884838099227(21)282, (01)00884838099227(21)13, (01)00884838099227(21)132, (01)00884838099227(21)209]; 722231 [(01)00884838116740(21)49, (01)00884838116740(21)21, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)35, (01)00884838116740(21)54, (01)00884838116740(21)32].
4. Model Number [UDI]: 722228 [(01)00884838099234(21)328, (01)00884838099234(21)522, (01)00884838099234(21)187, (01)00884838099234(21)113, (01)00884838099234(21)205, (01)00884838099234(21)567, (01)00884838099234(21)539, (01)00884838099234(21)156, (01)00884838099234(21)308, (01)00884838099234(21)335, (01)00884838099234(21)333, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)44, (01)00884838099234(21)569, (01)00884838099234(21)418, (01)00884838099234(21)525, (01)00884838099234(21)280, (01)00884838099234(21)616, (01)00884838099234(21)387, (01)00884838099234(21)568, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)556, (01)00884838099234(21)629, (01)00884838099234(21)102, (01)00884838099234(21)178, (01)00884838099234(21)299, (01)00884838099234(21)566, (01)00884838099234(21)508, (01)00884838099234(21)571, (01)00884838099234(21)493, (01)00884838099234(21)1, (01)00884838099234(21)434, (01)00884838099234(21)647, (01)00884838099234(21)317, 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(01)00884838110564(21)245, (01)00884838110564(21)34, (01)00884838110564(21)381, (01)00884838110564(21)132, (01)00884838110564(21)404, (01)00884838110564(21)325, (01)00884838110564(21)32, (01)00884838110564(21)205, (01)00884838110564(21)82, (01)00884838110564(21)332, (01)00884838110564(21)222, (01)00884838110564(21)138, (01)00884838110564(21)174, (01)00884838110564(21)311, (01)00884838110564(21)312, (01)00884838110564(21)121, (01)00884838110564(21)300, (01)00884838110564(21)90, (01)00884838110564(21)96, (01)00884838110564(21)231, (01)00884838110564(21)123, (01)00884838110564(21)424, (01)00884838110564(21)298, (01)00884838110564(21)264, (01)00884838110564(21)172, (01)00884838110564(21)160, (01)00884838110564(21)335, (01)00884838110564(21)75, (01)00884838110564(21)91, (01)00884838110564(21)292, (01)00884838110564(21)369, (01)00884838110564(21)223, (01)00884838110564(21)18, (01)00884838110564(21)86, (01)00884838110564(21)87, (01)00884838110564(21)418, (01)00884838110564(21)49, (01)00884838110564(21)385, (01)00884838110564(21)166, (01)00884838110564(21)72, (01)00884838110564(21)274, (01)00884838110564(21)47, (01)00884838110564(21)242, (01)00884838110564(21)324, (01)00884838110564(21)144, (01)00884838110564(21)355, (01)00884838110564(21)158, (01)00884838110564(21)234, (01)00884838110564(21)345, (01)00884838110564(21)22, (01)00884838110564(21)224, (01)00884838110564(21)197, (01)00884838110564(21)206, (01)00884838110564(21)198, (01)00884838110564(21)329, (01)00884838110564(21)249, (01)00884838110564(21)58, (01)00884838110564(21)133, (01)00884838110564(21)263, (01)00884838110564(21)193, (01)00884838110564(21)280, (01)00884838110564(21)118, (01)00884838110564(21)137, (01)00884838110564(21)303, (01)00884838110564(21)375, (01)00884838110564(21)439, (01)00884838110564(21)302, (01)00884838110564(21)103, (01)00884838110564(21)353, (01)00884838110564(21)196, (01)00884838110564(21)139, (01)00884838110564(21)408, (01)00884838110564(21)455, (01)00884838110564(21)173, (01)00884838110564(21)143, (01)00884838110564(21)29, (01)00884838110564(21)239, (01)00884838110564(21)15, (01)00884838110564(21)163, (01)00884838110564(21)437, (01)00884838110564(21)111, (01)00884838110564(21)252, (01)00884838110564(21)230, (01)00884838110564(21)42, (01)00884838110564(21)220, (01)00884838110564(21)213, (01)00884838110564(21)346, (01)00884838110564(21)347, (01)00884838110564(21)411, (01)00884838110564(21)362, (01)00884838110564(21)184, (01)00884838110564(21)185, (01)00884838110564(21)31, (01)00884838110564(21)30, (01)00884838110564(21)25, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)128, (01)00884838110564(21)36, (01)00884838110564(21)84, (01)00884838110564(21)16, (01)00884838110564(21)431, (01)00884838110564(21)475, (01)00884838110564(21)257, (01)00884838110564(21)243, (01)00884838110564(21)241, (01)00884838110564(21)262, (01)00884838110564(21)165, (01)00884838110564(21)464, (01)00884838110564(21)147, (01)00884838110564(21)248, (01)00884838110564(21)288].
5. Model Number [UDI]: 722067 [(01)00884838085350(21)128, (01)00884838085350(21)270, (01)00884838085350(21)251, (01)00884838085350(21)222, (01)00884838085350(21)262, (01)00884838085350(21)274, (01)00884838085350(21)218, (01)00884838085350(21)275, (01)00884838085350(21)127, (01)00884838085350(21)211, (01)00884838085350(21)212, (01)00884838085350(21)213, (01)00884838085350(21)210, (01)00884838085350(21)138, (01)00884838085350(21)254, (01)00884838085350(21)142, (01)00884838085350(21)60, (01)00884838085350(21)97, (01)00884838085350(21)45, (01)00884838085350(21)112, (01)00884838085350(21)134, (01)00884838085350(21)101, (01)00884838085350(21)100, (01)00884838085350(21)168, (01)00884838085350(21)235, (01)00884838085350(21)273, (01)00884838085350(21)176, (01)00884838085350(21)156, (01)00884838085350(21)276, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)202, (01)00884838085350(21)32, (01)00884838085350(21)38, (01)00884838085350(21)87, (01)00884838085350(21)56]; 722225 [(01)00884838099265(21)455, (01)00884838099265(21)284, (01)00884838099265(21)251, (01)00884838099265(21)468, (01)00884838099265(21)232, (01)00884838099265(21)230, (01)00884838099265(21)269, (01)00884838099265(21)345, (01)00884838099265(21)374, (01)00884838099265(21)241, (01)00884838099265(21)431, (01)00884838099265(21)450, (01)00884838099265(21)152, (01)00884838099265(21)145, (01)00884838099265(21)306, (01)00884838099265(21)140, (01)00884838099265(21)457, (01)00884838099265(21)314, (01)00884838099265(21)421, (01)00884838099265(21)422, (01)00884838099265(21)158, (01)00884838099265(21)267, (01)00884838099265(21)454, (01)00884838099265(21)438, (01)00884838099265(21)366, (01)00884838099265(21)173, (01)00884838099265(21)146, (01)00884838099265(21)196, (01)00884838099265(21)372, (01)00884838099265(21)254, (01)00884838099265(21)343, (01)00884838099265(21)201, (01)00884838099265(21)350, (01)00884838099265(21)373, (01)00884838099265(21)4, (01)00884838099265(21)385, (01)00884838099265(21)384, (01)00884838099265(21)214, (01)00884838099265(21)395, (01)00884838099265(21)427, (01)00884838099265(21)439, (01)00884838099265(21)133, (01)00884838099265(21)346, (01)00884838099265(21)471, (01)00884838099265(21)472, (01)00884838099265(21)253, (01)00884838099265(21)326, (01)00884838099265(21)252, (01)00884838099265(21)351, (01)00884838099265(21)309, (01)00884838099265(21)349, (01)00884838099265(21)342, (01)00884838099265(21)7, (01)00884838099265(21)159, (01)00884838099265(21)348, (01)00884838099265(21)17, (01)00884838099265(21)226, (01)00884838099265(21)114]; 722235 [(01)00884838116788(21)4, (01)00884838116788(21)3].
6. Model Number [UDI]: 722068 [(01)00884838085367(21)455, (01)00884838085367(21)330, (01)00884838085367(21)608, (01)00884838085367(21)302, (01)00884838085367(21)126, (01)00884838085367(21)468, (01)00884838085367(21)410, (01)00884838085367(21)548, (01)00884838085367(21)495, (01)00884838085367(21)537, (01)00884838085367(21)237, (01)00884838085367(21)236, (01)00884838085367(21)307, (01)00884838085367(21)577, (01)00884838085367(21)325, (01)00884838085367(21)480, (01)00884838085367(21)53, (01)00884838085367(21)491, (01)00884838085367(21)423, (01)00884838085367(21)614, (01)00884838085367(21)142, (01)00884838085367(21)376, (01)00884838085367(21)539, (01)00884838085367(21)140, (01)00884838085367(21)369, (01)00884838085367(21)97, (01)00884838085367(21)87, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838085367(21)550, (01)00884838085367(21)551, (01)00884838085367(21)448, (01)00884838085367(21)160, (01)00884838085367(21)83, (01)00884838085367(21)68, (01)00884838085367(21)434, (01)00884838085367(21)435, (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)338, (01)00884838085367(21)399, (01)00884838085367(21)339, (01)00884838085367(21)316, (01)00884838085367(21)555, (01)00884838085367(21)570, (01)00884838085367(21)347, (01)00884838085367(21)148, (01)00884838085367(21)38, (01)00884838085367(21)560, (01)00884838085367(21)318, (01)00884838085367(21)518, (01)00884838085367(21)250, (01)00884838085367(21)336, (01)00884838085367(21)185, (01)00884838085367(21)489, (01)00884838085367(21)254, (01)00884838085367(21)427, (01)00884838085367(21)591, (01)00884838085367(21)35, (01)00884838085367(21)227, (01)00884838085367(21)359, (01)00884838085367(21)129, (01)00884838085367(21)396, (01)00884838085367(21)515, (01)00884838085367(21)486, (01)00884838085367(21)543, (01)00884838085367(21)174, (01)00884838085367(21)484, (01)00884838085367(21)483, (01)00884838085367(21)425, (01)00884838085367(21)181, (01)00884838085367(21)408, (01)00884838085367(21)365, (01)00884838085367(21)540, (01)00884838085367(21)584, (01)00884838085367(21)553, (01)00884838085367(21)602, (01)00884838085367(21)617, (01)00884838085367(21)604, (01)00884838085367(21)593, (01)00884838085367(21)589, (01)00884838085367(21)526, (01)00884838085367(21)559, (01)00884838085367(21)612, (01)00884838085367(21)556, (01)00884838085367(21)557, (01)00884838085367(21)574, (01)00884838085367(21)603, (01)00884838085367(21)601, (01)00884838085367(21)609, (01)00884838085367(21)616, (01)00884838085367(21)597, (01)00884838085367(21)605, (01)00884838085367(21)575, (01)00884838085367(21)516, (01)00884838085367(21)624, (01)00884838085367(21)599, (01)00884838085367(21)563, (01)00884838085367(21)590, (01)00884838085367(21)600, (01)00884838085367(21)228, (01)00884838085367(21)380, (01)00884838085367(21)397, (01)00884838085367(21)180, (01)00884838085367(21)269, (01)00884838085367(21)268, (01)00884838085367(21)414, (01)00884838085367(21)562, (01)00884838085367(21)115, (01)00884838085367(21)291, (01)00884838085367(21)532, (01)00884838085367(21)533, (01)00884838085367(21)618, (01)00884838085367(21)549, (01)00884838085367(21)46, (01)00884838085367(21)249, (01)00884838085367(21)531, (01)00884838085367(21)290, (01)00884838085367(21)125, (01)00884838085367(21)102, (01)00884838085367(21)124, (01)00884838085367(21)145, (01)00884838085367(21)299, (01)00884838085367(21)317, (01)00884838085367(21)90, (01)00884838085367(21)157, (01)00884838085367(21)100, (01)00884838085367(21)186, (01)00884838085367(21)296, (01)00884838085367(21)189]; 722226 [(01)00884838099272(21)209, (01)00884838099272(21)786, (01)00884838099272(21)814, (01)00884838099272(21)469, (01)00884838099272(21)219, (01)00884838099272(21)987, (01)00884838099272(21)880, (01)00884838099272(21)509, (01)00884838099272(21)367, (01)00884838099272(21)243, (01)00884838099272(21)179, (01)00884838099272(21)250, (01)00884838099272(21)178, (01)00884838099272(21)674, (01)00884838099272(21)1062, (01)00884838099272(21)575, (01)00884838099272(21)1121, (01)00884838099272(21)176, (01)00884838099272(21)589, (01)00884838099272(21)576, (01)00884838099272(21)1046, (01)00884838099272(21)717, (01)00884838099272(21)697, (01)00884838099272(21)1126, (01)00884838099272(21)665, (01)00884838099272(21)416, (01)00884838099272(21)764, (01)00884838099272(21)386, (01)00884838099272(21)859, (01)00884838099272(21)1043, (01)00884838099272(21)957, (01)00884838099272(21)60, (01)00884838099272(21)423, (01)00884838099272(21)698, (01)00884838099272(21)331, (01)00884838099272(21)1097, (01)00884838099272(21)949, (01)00884838099272(21)718, (01)00884838099272(21)663, (01)00884838099272(21)1073, (01)00884838099272(21)982, (01)00884838099272(21)617, (01)00884838099272(21)604, (01)00884838099272(21)430, 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(01)00884838099272(21)745, (01)00884838099272(21)1033, (01)00884838099272(21)791, (01)00884838099272(21)591, (01)00884838099272(21)878, (01)00884838099272(21)86, (01)00884838099272(21)7, (01)00884838099272(21)768, (01)00884838099272(21)664, (01)00884838099272(21)85, (01)00884838099272(21)53, (01)00884838099272(21)52, (01)00884838099272(21)890, (01)00884838099272(21)815, (01)00884838099272(21)943, (01)00884838099272(21)729, (01)00884838099272(21)1079, (01)00884838099272(21)546, (01)00884838099272(21)753, (01)00884838099272(21)844, (01)00884838099272(21)276, (01)00884838099272(21)649, (01)00884838099272(21)618, (01)00884838099272(21)529]; 722236 [(01)00884838116801(21)10, (01)00884838116801(21)29, (01)00884838116801(21)244, (01)00884838116801(21)117, (01)00884838116801(21)201, (01)00884838116801(21)278, (01)00884838116801(21)34, (01)00884838116801(21)222, (01)00884838116801(21)216, (01)00884838116801(21)219, (01)00884838116801(21)156, (01)00884838116801(21)33, (01)00884838116801(21)66, 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7. Model Number [UDI]: 722078 [(01)00884838085251(21)465, (01)00884838085251(21)700, (01)00884838085251(21)402, (01)00884838085251(21)360, (01)00884838085251(21)279, (01)00884838085251(21)162, (01)00884838085251(21)986, (01)00884838085251(21)561, (01)00884838085251(21)689, (01)00884838085251(21)499, (01)00884838085251(21)135, (01)00884838085251(21)38, (01)00884838085251(21)476, (01)00884838085251(21)380, (01)00884838085251(21)453, (01)00884838085251(21)24, (01)00884838085251(21)690, (01)00884838085251(21)943, (01)00884838085251(21)898, (01)00884838085251(21)378, (01)00884838085251(21)439, (01)00884838085251(21)628, (01)00884838085251(21)511, (01)00884838085251(21)178, (01)00884838085251(21)266, (01)00884838085251(21)526, (01)00884838085251(21)746, (01)00884838085251(21)264, (01)00884838085251(21)361, (01)00884838085251(21)348, (01)00884838085251(21)897, (01)00884838085251(21)845, (01)00884838085251(21)1036, (01)00884838085251(21)374, (01)00884838085251(21)375, (01)00884838085251(21)564, 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(01)00884838099241(21)1018, (01)00884838099241(21)513, (01)00884838099241(21)345, (01)00884838099241(21)95, (01)00884838099241(21)13, (01)00884838099241(21)927, (01)00884838099241(21)901, (01)00884838099241(21)1224, (01)00884838099241(21)297, (01)00884838099241(21)263, (01)00884838099241(21)539, (01)00884838099241(21)494, (01)00884838099241(21)1260, (01)00884838099241(21)319, (01)00884838099241(21)320, (01)00884838099241(21)586, (01)00884838099241(21)300, (01)00884838099241(21)276, (01)00884838099241(21)493, (01)00884838099241(21)624, (01)00884838099241(21)368, (01)00884838099241(21)394, (01)00884838099241(21)971]; 722233 [(01)00884838116764(21)76, (01)00884838116764(21)12, (01)00884838116764(21)82, (01)00884838116764(21)245, (01)00884838116764(21)141, (01)00884838116764(21)27, (01)00884838116764(21)235, (01)00884838116764(21)117, (01)00884838116764(21)7, (01)00884838116764(21)205, (01)00884838116764(21)204, (01)00884838116764(21)203, (01)00884838116764(21)120, 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8. Model Number [UDI]: 722079 [(01)00884838085268(21)35, (01)00884838085268(21)43, (01)00884838085268(21)40, (01)00884838085268(21)246, (01)00884838085268(21)420, (01)00884838085268(21)564, (01)00884838085268(21)838, (01)00884838085268(21)47, (01)00884838085268(21)1086, (01)00884838085268(21)877, (01)00884838085268(21)703395, (01)00884838085268(21)716, (01)00884838085268(21)483, (01)00884838085268(21)1392, (01)00884838085268(21)335, (01)00884838085268(21)1410, (01)00884838085268(21)1230, (01)00884838085268(21)703615, (01)00884838085268(21)944, (01)00884838085268(21)1005, (01)00884838085268(21)697, (01)00884838085268(21)621, (01)00884838085268(21)703426, (01)00884838085268(21)360, (01)00884838085268(21)469, (01)00884838085268(21)857, (01)00884838085268(21)34, (01)00884838085268(21)797, (01)00884838085268(21)281, (01)00884838085268(21)939, (01)00884838085268(21)703407, (01)00884838085268(21)866, (01)00884838085268(21)354, (01)00884838085268(21)1361, (01)00884838085268(21)921, 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| FEI Number |
3042175844
|
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 6
Best Netherlands
|
Manufacturer Reason
for Recall | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | Philips Medical notified consignees on about 04/28/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were made aware of the issue and instructed to circulate the notification to all users of the system for awareness, that affected systems may continue to be used in accordance with their Instructions for Use (IFU), if the required position cannot be achieved using the Float Tabletop control for table movement, use alternative system movements (e.g., stand movement) where clinically feasible to adjust the relative position between the system and the patient, and avoid contact with sharp edges in the event that the Float Tabletop control is damaged.
Consignees were also instructed to maintain the notification letter with the documentation of the system until Philips corrects the system, ensure the notification is located where it can be viewed, notify customers if system has been transferred, and complete and return the provided Response Form.
Philips will install an auxiliary pan handle on all affected systems. A Philips representative will contact consignees to schedule the implementation of this correction. Philips expects to begin implementation of the correction by July 2026. |
|---|
| Quantity in Commerce | 5,537 units |
|---|
| Distribution | Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen |
|---|
| Total Product Life Cycle | TPLC Device Report |
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|
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
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