PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion under the following System Descriptions and

Hazard / Issue

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (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)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)74, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)147, (01)00884838099203(21)96, (01)00884838099203(21)92, (01)00884838099203(21)78, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)163, (01)00884838099203(21)67, (01)00884838099203(21)81, (01)00884838099203(21)22). 2. Model Numbers (UDI Numbers): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)513, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)479, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)502, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)102, (01)00884838085282(21)461, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, 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(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)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)496, (01)00884838085282(21)427, (01)00884838085282(21)341, (01)00884838085282(21)118, (01)00884838085282(21)174, (01)00884838085282(21)452, (01)00884838085282(21)168, (01)00884838085282(21)447, (01)00884838085282(21)198, (01)00884838085282(21)312, (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)43, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)12, (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)215, (01)00884838085282(21)144, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)175, (01)00884838085282(21)372, (01)00884838085282(21)429, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)437, (01)00884838085282(21)315, (01)00884838085282(21)134, (01)00884838085282(21)255, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)117, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)72), 722222 ((01)00884838099210(21)254, (01)00884838099210(21)226, (01)00884838099210(21)55, (01)00884838099210(21)44, (01)00884838099210(21)262, (01)00884838099210(21)37, (01)00884838099210(21)318, (01)00884838099210(21)269, (01)00884838099210(21)316, (01)00884838099210(21)307, (01)00884838099210(21)336, (01)00884838099210(21)174, (01)00884838099210(21)230, (01)00884838099210(21)182, (01)00884838099210(21)312, (01)00884838099210(21)172, (01)00884838099210(21)151, (01)00884838099210(21)138, (01)00884838099210(21)277, (01)00884838099210(21)224, (01)00884838099210(21)118, (01)00884838099210(21)119, (01)00884838099210(21)102, (01)00884838099210(21)88, (01)00884838099210(21)209, (01)00884838099210(21)145, (01)00884838099210(21)210, (01)00884838099210(21)89, (01)00884838099210(21)108, (01)00884838099210(21)132, (01)00884838099210(21)48, (01)00884838099210(21)4, (01)00884838099210(21)305, (01)00884838099210(21)80, (01)00884838099210(21)83, (01)00884838099210(21)47, (01)00884838099210(21)134, (01)00884838099210(21)222, (01)00884838099210(21)266, 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(01)00884838099210(21)218, (01)00884838099210(21)126), 722280 ((01)00884838103276(21)57, (01)00884838103276(21)43, (01)00884838103276(21)179, (01)00884838103276(21)65, (01)00884838103276(21)76, (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)44, (01)00884838103276(21)100, (01)00884838103276(21)164, (01)00884838103276(21)66, (01)00884838103276(21)135, (01)00884838103276(21)175, (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)37, (01)00884838103276(21)83, (01)00884838103276(21)87, (01)00884838103276(21)90, (01)00884838103276(21)105, (01)00884838103276(21)23, (01)00884838103276(21)30, (01)00884838103276(21)96, (01)00884838103276(21)107, (01)00884838103276(21)171, 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(01)00884838103276(21)124, (01)00884838103276(21)123, (01)00884838103276(21)125, (01)00884838103276(21)151, (01)00884838103276(21)39, (01)00884838103276(21)101, (01)00884838103276(21)41, (01)00884838103276(21)42, (01)00884838103276(21)53, (01)00884838103276(21)108, (01)00884838103276(21)119, (01)00884838103276(21)82, (01)00884838103276(21)33, (01)00884838103276(21)20, (01)00884838103276(21)63, (01)00884838103276(21)84, (01)00884838103276(21)145, (01)00884838103276(21)36, (01)00884838103276(21)59, (01)00884838103276(21)50, (01)00884838103276(21)110, (01)00884838103276(21)140, (01)00884838103276(21)117, (01)00884838103276(21)49, (01)00884838103276(21)60, (01)00884838103276(21)103, (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 Numbers (UDI Numbers): 722227 ((01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)246, (01)00884838099227(21)84, (01)00884838099227(21)29, (01)00884838099227(21)108, (01)00884838099227(21)62, (01)00884838099227(21)25, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)249, (01)00884838099227(21)215, (01)00884838099227(21)167, (01)00884838099227(21)83, (01)00884838099227(21)195, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)219, (01)00884838099227(21)256, (01)00884838099227(21)90, (01)00884838099227(21)69, (01)00884838099227(21)200, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)137, (01)00884838099227(21)294, (01)00884838099227(21)95, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)248, (01)00884838099227(21)106, (01)00884838099227(21)26, (01)00884838099227(21)44, (01)00884838099227(21)130, (01)00884838099227(21)58, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)259, (01)00884838099227(21)131). 4. Model Numbers (UDI Numbers): 722228 ((01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)47, (01)00884838099234(21)87, (01)00884838099234(21)38, (01)00884838099234(21)32, (01)00884838099234(21)25, (01)00884838099234(21)23, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)127, (01)00884838099234(21)91, (01)00884838099234(21)529, (01)00884838099234(21)145, (01)00884838099234(21)539, (01)00884838099234(21)308, (01)00884838099234(21)335, (01)00884838099234(21)333, (01)00884838099234(21)44, (01)00884838099234(21)418, (01)00884838099234(21)525, (01)00884838099234(21)280, (01)00884838099234(21)387, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)103, (01)00884838099234(21)176, (01)00884838099234(21)102, (01)00884838099234(21)178, (01)00884838099234(21)109, (01)00884838099234(21)16, (01)00884838099234(21)234, (01)00884838099234(21)463, (01)00884838099234(21)71, (01)00884838099234(21)317, (01)00884838099234(21)517, (01)00884838099234(21)203, (01)00884838099234(21)260, (01)00884838099234(21)107, (01)00884838099234(21)101, (01)00884838099234(21)99, (01)00884838099234(21)100, (01)00884838099234(21)108, (01)00884838099234(21)318, (01)00884838099234(21)75, (01)00884838099234(21)78, (01)00884838099234(21)531, (01)00884838099234(21)370, (01)00884838099234(21)464, (01)00884838099234(21)138, (01)00884838099234(21)496, (01)00884838099234(21)312, (01)00884838099234(21)223, (01)00884838099234(21)218, (01)00884838099234(21)513, (01)00884838099234(21)442, (01)00884838099234(21)174, (01)00884838099234(21)548, (01)00884838099234(21)84, (01)00884838099234(21)454, (01)00884838099234(21)346, (01)00884838099234(21)327, (01)00884838099234(21)196, (01)00884838099234(21)415, (01)00884838099234(21)118, (01)00884838099234(21)452, (01)00884838099234(21)179, (01)00884838099234(21)331, (01)00884838099234(21)297, (01)00884838099234(21)503, (01)00884838099234(21)412, (01)00884838099234(21)427, (01)00884838099234(21)488, (01)00884838099234(21)500, (01)00884838099234(21)365, (01)00884838099234(21)443, (01)00884838099234(21)90, (01)00884838099234(21)498, (01)00884838099234(21)284, (01)00884838099234(21)201, (01)00884838099234(21)171, (01)00884838099234(21)229, (01)00884838099234(21)332, (01)00884838099234(21)501, (01)00884838099234(21)306, (01)00884838099234(21)429, (01)00884838099234(21)56, (01)00884838099234(21)257, (01)00884838099234(21)430, (01)00884838099234(21)360, (01)00884838099234(21)352, (01)00884838099234(21)329, (01)00884838099234(21)197, (01)00884838099234(21)366, (01)00884838099234(21)345, (01)00884838099234(21)302, (01)00884838099234(21)166, (01)00884838099234(21)432, (01)00884838099234(21)361, (01)00884838099234(21)305, (01)00884838099234(21)542, (01)00884838099234(21)313, (01)00884838099234(21)220, (01)00884838099234(21)325, (01)00884838099234(21)405, (01)00884838099234(21)433, (01)00884838099234(21)342, (01)00884838099234(21)341, (01)00884838099234(21)184, (01)00884838099234(21)424, (01)00884838099234(21)425, (01)00884838099234(21)426, (01)00884838099234(21)497, (01)00884838099234(21)258, (01)00884838099234(21)183, (01)00884838099234(21)195, (01)00884838099234(21)314, (01)00884838099234(21)282, (01)00884838099234(21)402, (01)00884838099234(21)439, (01)00884838099234(21)421, (01)00884838099234(21)440, (01)00884838099234(21)446, (01)00884838099234(21)472, (01)00884838099234(21)320, (01)00884838099234(21)281, (01)00884838099234(21)480, (01)00884838099234(21)364, (01)00884838099234(21)182, (01)00884838099234(21)448, (01)00884838099234(21)283, (01)00884838099234(21)291, (01)00884838099234(21)473, (01)00884838099234(21)321, (01)00884838099234(21)476, (01)00884838099234(21)409, (01)00884838099234(21)376, (01)00884838099234(21)384, (01)00884838099234(21)534, (01)00884838099234(21)362, (01)00884838099234(21)489, (01)00884838099234(21)303, (01)00884838099234(21)413, (01)00884838099234(21)512, (01)00884838099234(21)404, (01)00884838099234(21)437, (01)00884838099234(21)336, (01)00884838099234(21)200, (01)00884838099234(21)344, (01)00884838099234(21)504, (01)00884838099234(21)94, (01)00884838099234(21)494, (01)00884838099234(21)408, (01)00884838099234(21)483, (01)00884838099234(21)449, (01)00884838099234(21)337, (01)00884838099234(21)438, (01)00884838099234(21)453, (01)00884838099234(21)106, (01)00884838099234(21)311, (01)00884838099234(21)324, (01)00884838099234(21)459, (01)00884838099234(21)477, (01)00884838099234(21)330, (01)00884838099234(21)386, (01)00884838099234(21)288, (01)00884838099234(21)167, (01)00884838099234(21)390, (01)00884838099234(21)261, (01)00884838099234(21)334, (01)00884838099234(21)304, (01)00884838099234(21)350, (01)00884838099234(21)212, (01)00884838099234(21)340, (01)00884838099234(21)515, (01)00884838099234(21)292, (01)00884838099234(21)173, (01)00884838099234(21)543, (01)00884838099234(21)217, (01)00884838099234(21)160, (01)00884838099234(21)82, (01)00884838099234(21)133, (01)00884838099234(21)208, (01)00884838099234(21)165, (01)00884838099234(21)378, (01)00884838099234(21)164, (01)00884838099234(21)228, (01)00884838099234(21)401, (01)00884838099234(21)161, (01)00884838099234(21)147, (01)00884838099234(21)146, (01)00884838099234(21)170, (01)00884838099234(21)295, (01)00884838099234(21)290, (01)00884838099234(21)316, (01)00884838099234(21)207), 722281 ((01)00884838110564(21)55, (01)00884838110564(21)21, (01)00884838110564(21)28, (01)00884838110564(21)27, (01)00884838110564(21)60, (01)00884838110564(21)24, (01)00884838110564(21)48, (01)00884838110564(21)17, (01)00884838110564(21)124, (01)00884838110564(21)64, (01)00884838110564(21)54, (01)00884838110564(21)19, (01)00884838110564(21)26, (01)00884838110564(21)80, (01)00884838110564(21)11, (01)00884838110564(21)9, (01)00884838110564(21)35, (01)00884838110564(21)76, (01)00884838110564(21)294, (01)00884838110564(21)229, (01)00884838110564(21)14, (01)00884838110564(21)33, (01)00884838110564(21)10, (01)00884838110564(21)284, (01)00884838110564(21)57, (01)00884838110564(21)50, (01)00884838110564(21)13, (01)00884838110564(21)34, (01)00884838110564(21)300, (01)00884838110564(21)231, (01)00884838110564(21)75, (01)00884838110564(21)22, (01)00884838110564(21)29, (01)00884838110564(21)31, (01)00884838110564(21)30, (01)00884838110564(21)36). 5. Model Numbers (UDI Numbers): 722067 ((01)00884838085350(21)42, (01)00884838085350(21)221, (01)00884838085350(21)278, (01)00884838085350(21)141, (01)00884838085350(21)133, (01)00884838085350(21)233, (01)00884838085350(21)146, (01)00884838085350(21)256, (01)00884838085350(21)270, (01)00884838085350(21)238, (01)00884838085350(21)187, (01)00884838085350(21)154, (01)00884838085350(21)157, (01)00884838085350(21)251, (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)95, (01)00884838085350(21)274, (01)00884838085350(21)218, (01)00884838085350(21)231, (01)00884838085350(21)169, (01)00884838085350(21)275, (01)00884838085350(21)265, (01)00884838085350(21)190, (01)00884838085350(21)203, (01)00884838085350(21)138, (01)00884838085350(21)53, (01)00884838085350(21)140, (01)00884838085350(21)266, (01)00884838085350(21)235, (01)00884838085350(21)272, (01)00884838085350(21)58, (01)00884838085350(21)47, (01)00884838085350(21)273, (01)00884838085350(21)64, (01)00884838085350(21)276, (01)00884838085350(21)232, (01)00884838085350(21)271, (01)00884838085350(21)35, (01)00884838085350(21)207, (01)00884838085350(21)226, (01)00884838085350(21)102, (01)00884838085350(21)105, (01)00884838085350(21)159, (01)00884838085350(21)170, (01)00884838085350(21)193, (01)00884838085350(21)118, (01)00884838085350(21)117, (01)00884838085350(21)85, (01)00884838085350(21)119), 722225 ((01)00884838099265(21)110, (01)00884838099265(21)37, (01)00884838099265(21)157, (01)00884838099265(21)284, (01)00884838099265(21)232, (01)00884838099265(21)230, (01)00884838099265(21)269, (01)00884838099265(21)345, (01)00884838099265(21)296, (01)00884838099265(21)374, (01)00884838099265(21)246, (01)00884838099265(21)128, (01)00884838099265(21)241, (01)00884838099265(21)180, (01)00884838099265(21)367, (01)00884838099265(21)292, (01)00884838099265(21)145, (01)00884838099265(21)306, (01)00884838099265(21)338, (01)00884838099265(21)314, (01)00884838099265(21)83, (01)00884838099265(21)422, (01)00884838099265(21)267, (01)00884838099265(21)223, (01)00884838099265(21)173, (01)00884838099265(21)8, (01)00884838099265(21)301, (01)00884838099265(21)146, (01)00884838099265(21)276, (01)00884838099265(21)109, (01)00884838099265(21)189, (01)00884838099265(21)200, (01)00884838099265(21)372, (01)00884838099265(21)312, (01)00884838099265(21)320, (01)00884838099265(21)393, (01)00884838099265(21)206, (01)00884838099265(21)327, (01)00884838099265(21)96, (01)00884838099265(21)446, (01)00884838099265(21)302, (01)00884838099265(21)242, (01)00884838099265(21)187, (01)00884838099265(21)169, (01)00884838099265(21)135, (01)00884838099265(21)134, (01)00884838099265(21)395, (01)00884838099265(21)116, (01)00884838099265(21)107, (01)00884838099265(21)133, (01)00884838099265(21)313, (01)00884838099265(21)346, (01)00884838099265(21)351, (01)00884838099265(21)349, (01)00884838099265(21)1, (01)00884838099265(21)234, (01)00884838099265(21)218, (01)00884838099265(21)342, (01)00884838099265(21)396, (01)00884838099265(21)348, (01)00884838099265(21)386, (01)00884838099265(21)213, (01)00884838099265(21)125, (01)00884838099265(21)190, (01)00884838099265(21)193, (01)00884838099265(21)341, (01)00884838099265(21)61, (01)00884838099265(21)221, (01)00884838099265(21)154, (01)00884838099265(21)67, (01)00884838099265(21)278, (01)00884838099265(21)162, (01)00884838099265(21)42). 6. Model Numbers (UDI Numbers): 722068 ((01)00884838085367(21)335, (01)00884838085367(21)205, (01)00884838085367(21)494, (01)00884838085367(21)564, (01)00884838085367(21)247, (01)00884838085367(21)85, (01)00884838085367(21)505, (01)00884838085367(21)271, (01)00884838085367(21)443, (01)00884838085367(21)354, (01)00884838085367(21)446, (01)00884838085367(21)73, (01)00884838085367(21)406, (01)00884838085367(21)528, (01)00884838085367(21)350, (01)00884838085367(21)462, (01)00884838085367(21)520, (01)00884838085367(21)469, (01)00884838085367(21)114, (01)00884838085367(21)477, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)276, (01)00884838085367(21)608, (01)00884838085367(21)473, (01)00884838085367(21)302, (01)00884838085367(21)126, (01)00884838085367(21)468, (01)00884838085367(21)454, (01)00884838085367(21)410, (01)00884838085367(21)231, (01)00884838085367(21)548, (01)00884838085367(21)495, (01)00884838085367(21)167, (01)00884838085367(21)537, 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