Class 2 Device Recall Azurion

• Date Initiated by Firm: April 28, 2026
• Date Posted: May 21, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2227-2026
• Recall Event ID: 98801
• Product Classification: Interventional Fluoroscopic X-Ray System - Product Code OWB
• Product: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
• Code Information: 1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)62, (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)18, (01)00884838085275(21)17, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)93, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (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)75, (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)85, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, 2. Azurion 3 M15; Model: 722064; UDI: (01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161, (01)00884838085282(21)162, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)89, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)213, (01)00884838085282(21)212, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)186, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)230, (01)00884838085282(21)176, (01)00884838085282(21)150, (01)00884838085282(21)149, (01)00884838085282(21)44, (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)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)155, (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)151, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)98, (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)121, (01)00884838085282(21)68, (01)00884838085282(21)91, (01)00884838085282(21)74, (01)00884838085282(21)73, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)11, (01)00884838085282(21)48, (01)00884838085282(21)147, (01)00884838085282(21)133, (01)00884838085282(21)7, (01)00884838085282(21)235, (01)00884838085282(21)120, (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)148, (01)00884838085282(21)182, (01)00884838085282(21)112, (01)00884838085282(21)86, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)136, (01)00884838085282(21)143, (01)00884838085282(21)226, (01)00884838085282(21)43, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)285, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)144, (01)00884838085282(21)227, (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)172, (01)00884838085282(21)210, (01)00884838085282(21)134, (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)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108, (01)00884838085282(21)37, 3. Azurion 7 B12; Model: 722067; UDI: (01)00884838085350(21)42, (01)00884838085350(21)173, (01)00884838085350(21)109, (01)00884838085350(21)192, (01)00884838085350(21)92, (01)00884838085350(21)103, (01)00884838085350(21)114, (01)00884838085350(21)69, (01)00884838085350(21)41, (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)132, (01)00884838085350(21)147, (01)00884838085350(21)104, (01)00884838085350(21)36, (01)00884838085350(21)70, (01)00884838085350(21)141, (01)00884838085350(21)26, (01)00884838085350(21)148, (01)00884838085350(21)133, (01)00884838085350(21)57, (01)00884838085350(21)190, (01)00884838085350(21)128, (01)00884838085350(21)151, (01)00884838085350(21)68, (01)00884838085350(21)111, (01)00884838085350(21)43, (01)00884838085350(21)33, (01)00884838085350(21)146, (01)00884838085350(21)187, (01)00884838085350(21)74, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)29, (01)00884838085350(21)59, (01)00884838085350(21)209, (01)00884838085350(21)95, (01)00884838085350(21)169, (01)00884838085350(21)127, (01)00884838085350(21)30, (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)140, (01)00884838085350(21)144, (01)00884838085350(21)60, (01)00884838085350(21)45, (01)00884838085350(21)107, (01)00884838085350(21)112, (01)00884838085350(21)134, (01)00884838085350(21)101, (01)00884838085350(21)100, (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)00884838099265(21)1, (01)00884838085350(21)55, (01)00884838085350(21)54, (01)00884838085350(21)165, (01)00884838085350(21)25, (01)00884838085350(21)35, (01)00884838085350(21)149, (01)00884838085350(21)32, (01)00884838085350(21)224, (01)00884838085350(21)76, (01)00884838085350(21)108, (01)00884838099265(21)17, (01)00884838085350(21)48, (01)00884838085350(21)102, (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)186, (01)00884838085350(21)130, (01)00884838085350(21)161, (01)00884838085350(21)120, (01)00884838085350(21)170, (01)00884838085350(21)171, (01)00884838085350(21)80, (01)00884838085350(21)28, (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)167, (01)00884838085350(21)78, (01)00884838085350(21)86, (01)00884838085350(21)91, (01)00884838085350(21)37, (01)00884838085350(21)72, (01)00884838085350(21)88, (01)00884838085350(21)27, (01)00884838085350(21)121, (01)00884838085350(21)179, (01)00884838085350(21)183, (01)00884838085350(21)117, (01)00884838085350(21)118, (01)00884838085350(21)85, (01)00884838085350(21)89, (01)00884838085350(21)90, (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)39, (01)00884838085350(21)56, (01)00884838085350(21)139, (01)00884838085350(21)61; 4. Azurion 7 B20; Model: 722068; UDI: (01)00884838085367(21)178, (01)00884838085367(21)335, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (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)42, (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)239, (01)00884838085367(21)271, (01)00884838085367(21)104, (01)00884838085367(21)370, (01)00884838085367(21)322, (01)00884838085367(21)136, (01)00884838085367(21)373, (01)00884838085367(21)308, (01)00884838085367(21)354, (01)00884838085367(21)75, (01)00884838085367(21)279, (01)00884838085367(21)400, (01)00884838085367(21)196, (01)00884838085367(21)110, (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)329, (01)00884838085367(21)184, (01)00884838085367(21)350, (01)00884838085367(21)304, (01)00884838085367(21)319, (01)00884838085367(21)490, (01)00884838085367(21)243, (01)00884838085367(21)103, (01)00884838085367(21)262, (01)00884838085367(21)261, (01)00884838085367(21)277, (01)00884838085367(21)150, (01)00884838085367(21)172, (01)00884838085367(21)117, (01)00884838085367(21)356, (01)00884838085367(21)130, (01)00884838085367(21)146, (01)00884838085367(21)143, (01)00884838085367(21)84, (01)00884838085367(21)251, (01)00884838085367(21)361, (01)00884838085367(21)76, (01)00884838085367(21)270, (01)00884838085367(21)114, (01)00884838085367(21)232, (01)00884838085367(21)137, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)337, (01)00884838085367(21)101, (01)00884838085367(21)213, (01)00884838085367(21)111, (01)00884838085367(21)82, (01)00884838085367(21)113, (01)00884838085367(21)275, (01)00884838085367(21)265, (01)00884838085367(21)459, (01)00884838085367(21)276, (01)00884838085367(21)62, (01)00884838085367(21)302, (01)00884838085367(21)88, (01)00884838085367(21)126, (01)00884838085367(21)211, (01)00884838085367(21)283, (01)00884838085367(21)231, (01)00884838085367(21)207, (01)00884838085367(21)167, (01)00884838085367(21)289, (01)00884838085367(21)233, (01)00884838085367(21)173, (01)00884838085367(21)204, (01)00884838085367(21)77, (01)00884838085367(21)313, (01)00884838085367(21)236, (01)00884838085367(21)237, (01)00884838085367(21)133, (01)00884838085367(21)280, (01)00884838085367(21)307, (01)00884838085367(21)210, (01)00884838085367(21)258, (01)00884838085367(21)328, (01)00884838085367(21)325, (01)00884838085367(21)199, (01)00884838085367(21)53, (01)00884838085367(21)364, (01)00884838085367(21)491, (01)00884838085367(21)246, (01)00884838085367(21)142, (01)00884838085367(21)257, (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)44, (01)00884838099272(21)809, (01)00884838085367(21)242, (01)00884838085367(21)238, (01)00884838085367(21)160, (01)00884838085367(21)83, (01)00884838085367(21)68, (01)00884838085367(21)230, (01)00884838085367(21)360, (01)00884838085367(21)93, (01)00884838085367(21)36, (01)00884838099272(21)4, (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)215, (01)00884838085367(21)399, (01)00884838085367(21)338, (01)00884838085367(21)339, (01)00884838085367(21)316, (01)00884838085367(21)134, (01)00884838085367(21)38, (01)00884838085367(21)158, (01)00884838085367(21)318, (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)37, (01)00884838085367(21)79, (01)00884838085367(21)254, (01)00884838085367(21)394, (01)00884838085367(21)71, (01)00884838085367(21)47, (01)00884838085367(21)292, (01)00884838085367(21)35, (01)00884838085367(21)293, (01)00884838085367(21)227, (01)00884838085367(21)359, (01)00884838085367(21)387, (01)00884838085367(21)168, (01)00884838085367(21)128, (01)00884838085367(21)129, (01)00884838085367(21)69, (01)00884838085367(21)174, (01)00884838085367(21)483, (01)00884838085367(21)334, (01)00884838085367(21)181, (01)00884838085367(21)166, (01)00884838085367(21)141, (01)00884838085367(21)365, (01)00884838085367(21)198, (01)00884838085367(21)228, (01)00884838085367(21)380, (01)00884838085367(21)420, (01)00884838085367(21)212, (01)00884838085367(21)180, (01)00884838085367(21)268, (01)00884838085367(21)269, (01)00884838085367(21)74, (01)00884838085367(21)115, (01)00884838085367(21)349, (01)00884838085367(21)291, 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Azurion 7 M12; Model: 722078; UDI: (01)00884838085251(21)302, (01)00884838085251(21)585, (01)00884838085251(21)410, (01)00884838085251(21)523, (01)00884838085251(21)293, (01)00884838085251(21)291, (01)00884838085251(21)536, (01)00884838085251(21)537, (01)00884838085251(21)613, (01)00884838085251(21)598, (01)00884838085251(21)224, (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)438, (01)00884838085251(21)437, (01)00884838085251(21)456, (01)00884838085251(21)566, (01)00884838085251(21)488, (01)00884838085251(21)550, (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)165, (01)00884838085251(21)445, (01)00884838085251(21)539, (01)00884838085251(21)654, (01)00884838085251(21)656, (01)00884838085251(21)658, 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(01)00884838085251(21)871, (01)00884838085251(21)18, (01)00884838085251(21)551, (01)00884838085251(21)543, (01)00884838085251(21)516, (01)00884838085251(21)12, (01)00884838085251(21)155, (01)00884838085251(21)446, (01)00884838085251(21)685, (01)00884838085251(21)715, (01)00884838085251(21)225, (01)00884838085251(21)582, (01)00884838085251(21)19, (01)00884838085251(21)435, (01)00884838085251(21)16, (01)00884838085251(21)11, (01)00884838085251(21)167, (01)00884838085251(21)664, (01)00884838085251(21)508, (01)00884838085251(21)530; 6. Azurion 7 M12; Model: 722223; UDI: (01)00884838099241(21)61, (01)00884838099241(21)6, (01)00884838099241(21)12, (01)00884838099241(21)2; 7. Azurion 7 M20; Model: 722079; UDI: (01)00884838085268(21)1023, (01)00884838085268(21)645, (01)00884838085268(21)646, (01)00884838085268(21)1013, (01)00884838085268(21)460, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838085268(21)890, (01)00884838085268(21)1137, (01)00884838085268(21)1048, (01)00884838085268(21)401, (01)00884838085268(21)1010, (01)00884838085268(21)1054, (01)00884838085268(21)536, (01)00884838085268(21)534, (01)00884838085268(21)535, (01)00884838085268(21)266, (01)00884838085268(21)818, (01)00884838085268(21)412, (01)00884838085268(21)617, (01)00884838085268(21)246, (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)809, (01)00884838085268(21)848, (01)00884838085268(21)1033, (01)00884838085268(21)891, (01)00884838085268(21)836, (01)00884838085268(21)1155, (01)00884838085268(21)466, 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Azurion 7 M20; Model: 722079; UDI: (01)00884838099258(21)44, (01)00884838099258(21)56, (01)00884838099258(21)78, (01)00884838099258(21)6, (01)00884838099258(21)1595, (01)00884838099258(21)4, (01)00884838099258(21)2666, (01)00884838099258(21)132, (01)00884838099258(21)3
• FEI Number: 3042175844
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 6; Best Netherlands
• Manufacturer Reason for Recall: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
• FDA Determined Cause: Component design/selection
• Action: On April 28, 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 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. 3. Keep this 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. 4. If you experience the issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issue Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. Your local Philips representative will contact you to schedule a visit to replace the deaeration hose once available.
• Quantity in Commerce: 1651 units (592 US, 1359 OUS)
• Distribution: Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, 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.