Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended

Summary

The FDA issued a Class II for Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the .

Details

Product Description

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

Lot/Code Info: Model Number: 001015. Software Version Number R1.x. UDI Number: (01)00884838099272(21)153, (01)00884838099272(21)67, (01)00884838099272(21)675, (01)00884838085367(21)178, (01)00884838099272(21)112, (01)00884838085367(21)335, (01)00884838116801(21)345, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838099272(21)113, (01)00884838099272(21)121, (01)00884838116801(21)24, (01)00884838085367(21)170, (01)00884838099258(21)1150, (01)00884838116801(21)17, (01)00884838116801(21)25, (01)00884838059061(21)639, (01)00884838085268(21)856, (01)00884838116801(21)180, (01)00884838116801(21)227, (01)00884838099272(21)239, (01)00884838099272(21)105, (01)00884838116801(21)235, (01)00884838099272(21)678, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838085367(21)564, (01)00884838085268(21)716, (01)00884838085367(21)440, (01)00884838116801(21)226, (01)00884838099272(21)197, (01)00884838099272(21)380, (01)00884838059115(21)274, (01)00884838085367(21)247, (01)00884838085367(21)225, (01)00884838099272(21)592, (01)00884838099272(21)593, (01)00884838099272(21)319, (01)00884838099272(21)339, (01)00884838099272(21)182, (01)00884838099258(21)1234, (01)00884838085367(21)64, (01)00884838116801(21)20, (01)00884838099272(21)272, (01)00884838099272(21)680, (01)00884838085367(21)153, (01)00884838099272(21)350, (01)00884838099272(21)280, (01)00884838116801(21)208, (01)00884838116801(21)205, (01)00884838116801(21)36, (01)00884838085367(21)85, (01)00884838085367(21)89, (01)00884838085367(21)320, (01)00884838099272(21)144, (01)00884838085367(21)109, (01)00884838085367(21)407, (01)00884838099272(21)779, (01)00884838116801(21)81, (01)00884838085367(21)505, (01)00884838059115(21)277, (01)00884838099272(21)559, (01)00884838085367(21)443, (01)00884838099272(21)98, (01)00884838099272(21)343, (01)00884838116801(21)147, (01)00884838116801(21)148, (01)00884838085367(21)104, (01)00884838099272(21)876, (01)00884838059115(21)168, (01)00884838099272(21)1021, (01)00884838099272(21)244, (01)00884838116801(21)31, (01)00884838099272(21)332, (01)00884838099272(21)781, (01)00884838099272(21)782, (01)00884838085367(21)524, (01)00884838099272(21)534, (01)00884838099272(21)129, (01)00884838099272(21)442, (01)00884838085367(21)400, (01)00884838059061(21)575, (01)00884838099272(21)189, (01)00884838099272(21)190, (01)00884838085367(21)510, (01)00884838116801(21)252, (01)00884838085367(21)110, (01)00884838099272(21)208, (01)00884838085367(21)73, (01)00884838085367(21)288, (01)00884838085268(21)281, (01)00884838116801(21)21, (01)00884838099272(21)400, (01)00884838085367(21)406, (01)00884838099272(21)326, (01)00884838085367(21)528, (01)00884838099272(21)323, (01)00884838116801(21)118, (01)00884838116801(21)50, (01)00884838085268(21)852, (01)00884838099258(21)101, (01)00884838085367(21)457, (01)00884838085367(21)470, (01)00884838085367(21)472, (01)00884838099272(21)778, (01)00884838116801(21)39, (01)00884838085268(21)704281, (01)00884838085367(21)319, (01)00884838085367(21)520, (01)00884838085367(21)490, (01)00884838085268(21)703418, (01)00884838116801(21)48, (01)00884838099272(21)482, (01)00884838116801(21)221, (01)00884838085367(21)150, (01)00884838099258(21)46, (01)00884838085367(21)172, (01)00884838085268(21)29, (01)00884838059115(21)61, (01)00884838099272(21)793, (01)00884838116801(21)68, (01)00884838085367(21)117, (01)00884838085268(21)930, (01)00884838099272(21)1017, (01)00884838085367(21)130, (01)00884838059115(21)264, (01)00884838099272(21)410, (01)00884838099272(21)508, (01)00884838059115(21)167, (01)00884838099272(21)419, (01)00884838085367(21)469, (01)00884838099272(21)472, (01)00884838059061(21)327, (01)00884838085268(21)21, (01)00884838116801(21)51, (01)00884838099272(21)383, (01)00884838085367(21)76, (01)00884838099272(21)59, (01)00884838099272(21)361, (01)00884838085367(21)477, (01)00884838099272(21)1002, (01)00884838085367(21)137, (01)00884838059061(21)580, (01)00884838116801(21)38, (01)00884838116801(21)22, (01)00884838099272(21)398, (01)00884838085367(21)107, (01)00884838116801(21)186, (01)00884838099272(21)75, (01)00884838054202(21)534, (01)00884838085268(21)255, (01)00884838116801(21)32, (01)00884838085367(21)282, (01)00884838099258(21)2557, (01)00884838099272(21)786, (01)00884838116801(21)276, (01)00884838099272(21)19, (01)00884838099272(21)1125, (01)00884838085367(21)487, (01)00884838099272(21)814, (01)00884838085367(21)213, (01)00884838099272(21)469, (01)00884838059115(21)172, (01)00884838099272(21)219, (01)00884838085367(21)82, (01)00884838099272(21)296, (01)00884838059061(21)607, (01)00884838099272(21)704, (01)00884838054226(21)102, (01)00884838059115(21)110, (01)00884838085367(21)485, (01)00884838085268(21)783, (01)00884838099258(21)2937, (01)00884838085367(21)276, (01)00884838085268(21)703565, (01)00884838116771(21)187, (01)00884838099272(21)693, (01)00884838099272(21)510, (01)00884838099272(21)882, (01)00884838099258(21)2852, (01)00884838099258(21)2931, (01)00884838099272(21)226, (01)00884838085367(21)559, (01)00884838085268(21)703844, (01)00884838085268(21)703893, (01)00884838099272(21)509, (01)00884838116801(21)289, (01)00884838116801(21)67, (01)00884838059115(21)332, (01)00884838099272(21)1050, (01)00884838099258(21)497, (01)00884838099272(21)201, (01)00884838099272(21)202, (01)00884838099272(21)303, (01)00884838099272(21)184, (01)00884838099272(21)250, (01)00884838054202(21)1914, (01)00884838099272(21)1139, (01)00884838059115(21)142, (01)00884838099272(21)368, (01)00884838099272(21)950, (01)00884838099272(21)829, (01)00884838054226(21)11, (01)00884838099272(21)249, (01)00884838085367(21)302, (01)00884838085367(21)314, (01)00884838059054(21)1144, (01)00884838099272(21)576, (01)00884838085367(21)88, (01)00884838085367(21)211, (01)00884838085367(21)468, (01)00884838085367(21)422, (01)00884838085268(21)704300, (01)00884838099272(21)665, (01)00884838099272(21)764, (01)00884838099272(21)595, (01)00884838085367(21)454, (01)00884838099258(21)799, (01)00884838099258(21)800, (01)00884838099272(21)721, (01)00884838085367(21)283, (01)00884838085367(21)231, (01)00884838085367(21)548, (01)00884838099258(21)2555, (01)00884838099272(21)1006, (01)00884838059122(21)35, (01)00884838099272(21)498, (01)00884838099272(21)60, (01)00884838085367(21)207, (01)00884838085367(21)167, (01)00884838099258(21)1976, (01)00884838099258(21)2025, (01)00884838085367(21)537, (01)00884838085268(21)703712, (01)00884838085367(21)438, (01)00884838059115(21)151, (01)00884838099272(21)698, (01)00884838099272(21)331, (01)00884838085367(21)536, (01)00884838099272(21)378, (01)00884838116771(21)160, (01)00884838085367(21)204, (01)00884838099258(21)765, (01)00884838099258(21)1470, (01)00884838099272(21)393, (01)00884838116801(21)352, (01)00884838085367(21)77, (01)00884838116801(21)300, (01)00884838099258(21)778, (01)00884838099258(21)2541, (01)00884838099272(21)718, (01)00884838099272(21)663, (01)00884838099272(21)195, , (01)00884838099258(21)1338, (01)00884838116801(21)173, (01)00884838085367(21)236, (01)00884838085367(21)237, (01)00884838099272(21)775, (01)00884838099258(21)828, (01)00884838059115(21)232, (01)00884838085367(21)133, (01)00884838054202(21)1955, (01)00884838085268(21)703753, (01)00884838099272(21)282, (01)00884838116801(21)117, (01)00884838085367(21)280, (01)00884838059115(21)395, (01)00884838099258(21)2515, (01)00884838099272(21)785, (01)00884838059115(21)292, (01)00884838085367(21)307, (01)00884838099272(21)221, (01)00884838059115(21)380, (01)00884838099272(21)604, (01)00884838099272(21)415, (01)00884838099272(21)61, (01)00884838059115(21)183, (01)00884838085367(21)328, (01)00884838099258(21)720, (01)00884838099272(21)762, (01)00884838099272(21)1102, (01)00884838099272(21)306, (01)00884838085268(21)778, (01)00884838085268(21)548, (01)00884838099258(21)1581, (01)00884838099258(21)977, (01)00884838099272(21)83, (01)00884838099272(21)199, (01)00884838085268(21)1429, (01)00884838099258(21)675, (01)00884838116771(21)261, (01)00884838099272(21)898, (01)00884838085367(21)480, (01)00884838085367(21)53, (01)00884838085367(21)72, (01)00884838099272(21)899, (01)00884838085367(21)491, (01)00884838085367(21)423, (01)00884838099272(21)944, (01)00884838085367(21)509, (01)00884838099258(21)548, (01)00884838099258(21)3546, (01)00884838085367(21)246, (01)00884838059115(21)161, (01)00884838085367(21)614, (01)00884838099272(21)335, (01)00884838099272(21)1123, (01)00884838116801(21)34, (01)00884838099272(21)363, (01)00884838085367(21)376, (01)00884838054219(21)106, (01)00884838059115(21)372, (01)00884838085268(21)1239, (01)00884838054202(21)611, (01)00884838116801(21)122, (01)00884838085367(21)539, (01)00884838099258(21)771, (01)00884838059115(21)252, (01)00884838099272(21)626, (01)00884838099258(21)2592, (01)00884838099272(21)501, (01)00884838085367(21)140, (01)00884838085268(21)290, (01)00884838116801(21)374, (01)00884838085367(21)369, (01)00884838085367(21)508, (01)00884838085367(21)97, (01)00884838085268(21)464, (01)00884838099258(21)2850, (01)00884838054202(21)1540, (01)00884838085367(21)87, (01)00884838099272(21)449, (01)00884838116801(21)326, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838099272(21)974, (01)00884838085367(21)44, (01)00884838085367(21)301, (01)00884838085367(21)550, (01)00884838099272(21)344, (01)00884838099272(21)984, (01)00884838099272(21)487, (01)00884838059115(21)213, (01)00884838099272(21)686, (01)00884838099272(21)327, (01)00884838099272(21)424, (01)00884838099272(21)684, (01)00884838085367(21)478, (01)00884838099272(21)298, (01)00884838099272(21)1049, (01)00884838116801(21)207, (01)00884838054202(21)1893, (01)00884838099272(21)259, (01)00884838099258(21)2864, (01)00884838099272(21)140, (01)00884838059115(21)169, (01)00884838059061(21)295, , (01)00884838099272(21)506, (01)00884838099258(21)3598, (01)00884838099258(21)2921, (01)00884838099258(21)2947, (01)00884838099258(21)2424, (01)00884838085268(21)703966, (01)00884838099258(21)2105, (01)00884838099258(21)2101, (01)00884838099258(21)3383, (01)00884838099272(21)263, (01)00884838099258(21)3416, (01)00884838099258(21)620, (01)00884838099258(21)2932, (01)00884838099272(21)490, (01)00884838059061(21)110, (01)00884838099272(21)633, (01)00884838099272(21)396, (01)00884838116771(21)868, (01)00884838099272(21)547, (01)00884838116801(21)311, (01)00884838085367(21)160, (01)00884838099272(21)631, (01)00884838116771(21)190, (01)00884838085268(21)704258, (01)00884838085268(21)949, (01)00884838099258(21)632, (01)00884838099258(21)1766, (01)00884838099258(21)2872, (01)00884838099272(21)514, (01)00884838085367(21)68, (01)00884838085268(21)760, (01)00884838099258(21)3570, (01)00884838085268(21)961, (01)00884838059115(21)192, (01)00884838116771(21)658, (01)00884838116801(21)57, (01)00884838099272(21)17, (01)00884838099272(21)422, (01)00884838099272(21)420, (01)00884838099272(21)247, (01)00884838099272(21)432, (01)00884838099272(21)539, (01)00884838085367(21)360, (01)00884838116801(21)169, (01)00884838099272(21)245, (01)00884838099272(21)911, (01)00884838099272(21)132, (01)00884838099272(21)133, (01)00884838099258(21)1814, (01)00884838099258(21)2134, (01)00884838099272(21)586, (01)00884838099272(21)622, (01)00884838099272(21)228, (01)00884838116801(21)44, (01)00884838099258(21)1051, (01)00884838099258(21)1052, (01)00884838099258(21)2277, (01)00884838099272(21)45, (01)00884838085367(21)179, (01)00884838085367(21)306, (01)00884838085367(21)182, (01)00884838099272(21)485, (01)00884838085268(21)493, (01)00884838085367(21)327, (01)00884838099258(21)2618, (01)00884838099272(21)448, (01)00884838099272(21)507, (01)00884838099258(21)2575, (01)00884838099272(21)97, (01)00884838054226(21)133, (01)00884838099272(21)497, (01)00884838099258(21)1700, (01)00884838099258(21)2987, (01)00884838099258(21)3212, (01)00884838099258(21)1815, (01)00884838085367(21)244, (01)00884838059115(21)170, (01)00884838099272(21)685, (01)00884838059115(21)77, (01)00884838116801(21)274, (01)00884838059115(21)273, (01)00884838099258(21)2812, (01)00884838099258(21)2835, (01)00884838099272(21)1076, (01)00884838059115(21)229, (01)00884838085268(21)703935, (01)00884838099258(21)2103, (01)00884838099272(21)543, (01)00884838099272(21)66, (01)00884838085367(21)339, (01)00884838099272(21)542, (01)00884838099272(21)550, (01)00884838099272(21)551, (01)00884838099272(21)484, (01)00884838099272(21)504, (01)00884838099272(21)18, (01)00884838099258(21)545, (01)00884838116771(21)751, (01)00884838099258(21)1030, (01)00884838099272(21)1132, (01)00884838059054(21)1090, (01)00884838099272(21)752, (01)00884838059115(21)248, (01)00884838116801(21)113, (01)00884838099272(21)408, (01)00884838116771(21)562, (01)00884838085268(21)571, (01)00884838099258(21)520, (01)00884838116771(21)702, (01)00884838099272(21)238, (01)00884838099272(21)299, (01)00884838085367(21)318, (01)00884838085367(21)518, (01)00884838099258(21)3533, (01)00884838099272(21)404, (01)00884838059115(21)258, (01)00884838059115(21)289, (01)00884838085367(21)185, (01)00884838085268(21)682, (01)00884838116801(21)292, (01)00884838099258(21)358, (01)00884838099272(21)84, (01)00884838099258(21)2224, (01)00884838085367(21)50, (01)00884838059115(21)269, (01)00884838085367(21)521, (01)00884838099272(21)924, (01)00884838099272(21)224, (01)00884838085367(21)79, (01)00884838099258(21)1984, (01)00884838059115(21)141, (01)00884838116801(21)284, (01)00884838116801(21)285, (01)00884838059115(21)391, (01)00884838116771(21)504, (01)00884838085367(21)529, (01)00884838059122(21)38, (01)00884838116801(21)193, (01)00884838099258(21)2102, (01)00884838099272(21)261, (01)00884838085367(21)394, (01)00884838085268(21)889, (01)00884838099272(21)956, (01)00884838099272(21)1077, (01)00884838116771(21)51, (01)00884838099272(21)320, (01)00884838116801(21)297, (01)00884838099258(21)635, (01)00884838099272(21)710, (01)00884838085367(21)292, (01)00884838116801(21)347, (01)00884838085367(21)497, (01)00884838116801(21)321, (01)00884838054202(21)1125, (01)00884838054226(21)135, (01)00884838059115(21)281, (01)00884838099272(21)1072, (01)00884838099258(21)1272, (01)00884838085367(21)35, (01)00884838059115(21)246, (01)00884838099272(21)235, (01)00884838099272(21)727, (01)00884838099258(21)3412, (01)00884838059115(21)256, (01)00884838099258(21)3204, (01)00884838099272(21)621, (01)00884838085268(21)703346, (01)00884838099258(21)2719, (01)00884838085268(21)521, (01)00884838059115(21)233, (01)00884838059115(21)348, (01)00884838099272(21)765, (01)00884838099272(21)194, (01)00884838085268(21)586, (01)00884838085268(21)498, (01)00884838059115(21)204, (01)00884838099272(21)451, (01)00884838059122(21)37, (01)00884838116801(21)269, (01)00884838116801(21)102, (01)00884838085268(21)967, (01)00884838099258(21)3481, (01)00884838099272(21)275, (01)00884838099272(21)352, (01)00884838099272(21)630, (01)00884838085367(21)486, (01)00884838116801(21)132, (01)00884838085367(21)543, (01)00884838059115(21)206, (01)00884838085367(21)453, (01)00884838099272(21)1047, (01)00884838099258(21)2230, (01)00884838099272(21)349, (01)00884838085367(21)174, (01)00884838085367(21)483, (01)00884838085268(21)642, (01)00884838099272(21)854, (01)00884838099272(21)888, (01)00884838116801(21)189, (01)00884838085367(21)425, (01)00884838085367(21)181, (01)00884838054202(21)1411, (01)00884838085367(21)141, (01)00884838059061(21)53, (01)00884838099272(21)670, (01)00884838099272(21)739, (01)00884838085367(21)471, (01)00884838099272(21)1115, (01)00884838099258(21)3716, (01)00884838099258(21)2061, (01)00884838099258(21)1927, (01)00884838085268(21)704058, (01)00884838085367(21)602, (01)00884838099258(21)3436, (01)00884838099272(21)574, (01)00884838099272(21)741, (01)00884838099258(21)1631, (01)00884838085367(21)593, (01)00884838085268(21)704073, (01)00884838085268(21)704291, (01)00884838099272(21)1137, (01)00884838085367(21)589, (01)00884838099272(21)632, (01)00884838099258(21)1946, (01)00884838099258(21)1990, (01)00884838085268(21)704293, (01)00884838099258(21)2216, (01)00884838099272(21)1148, (01)00884838099258(21)2491, (01)00884838099258(21)2492, (01)00884838099258(21)2169, (01)00884838099272(21)662, (01)00884838099272(21)825, (01)00884838099272(21)1075, (01)00884838099272(21)744, (01)00884838099258(21)3683, (01)00884838099258(21)2337, (01)00884838099258(21)2338, (01)00884838099258(21)2823, (01)00884838099258(21)2825, (01)00884838099258(21)2109, (01)00884838099272(21)549, (01)00884838099272(21)1023, (01)00884838085367(21)612, (01)00884838099258(21)3689, (01)00884838099258(21)772, (01)00884838085268(21)703975, (01)00884838085367(21)574, (01)00884838099272(21)1135, (01)00884838099272(21)751, (01)00884838099272(21)1036, (01)00884838085268(21)703803, (01)00884838099258(21)3494, (01)00884838059115(21)358, (01)00884838099258(21)1746, (01)00884838085367(21)616, (01)00884838099258(21)2815, (01)00884838099272(21)798, (01)00884838099258(21)2091, (01)00884838099272(21)886, (01)00884838059115(21)418, (01)00884838099272(21)1128, (01)00884838099258(21)2551, (01)00884838099272(21)979, (01)00884838054202(21)1761, (01)00884838099258(21)2203, (01)00884838110571(21)35, (01)00884838110571(21)8, (01)00884838099272(21)669, (01)00884838054226(21)162, (01)00884838116801(21)182, (01)00884838059115(21)388, (01)00884838085268(21)1034, (01)00884838099272(21)29, (01)00884838085367(21)600, (01)00884838085268(21)704159, (01)00884838085268(21)704162, (01)00884838099258(21)2251, (01)00884838099272(21)817, (01)00884838085367(21)228, (01)00884838085367(21)380, (01)00884838099272(21)743, (01)00884838085268(21)398, (01)00884838085367(21)397, (01)00884838099258(21)2015, (01)00884838085367(21)475, (01)00884838099272(21)131, (01)00884838099258(21)209, (01)00884838085367(21)180, (01)00884838085268(21)1255, (01)00884838099272(21)563, (01)00884838059061(21)378, (01)00884838085268(21)1045, (01)00884838099258(21)3734, (01)00884838099234(21)691, (01)00884838099272(21)945, (01)00884838085367(21)268, (01)00884838085367(21)269, (01)00884838085367(21)414, (01)00884838116771(21)245, (01)00884838099258(21)1579, (01)00884838099272(21)50, (01)00884838054226(21)116, (01)00884838059115(21)354, (01)00884838059115(21)355, (01)00884838059115(21)159, (01)00884838059061(21)58, (01)00884838085367(21)349, (01)00884838085268(21)941, (01)00884838099258(21)528, (01)00884838099272(21)198, (01)00884838099272(21)168, , (01)00884838085268(21)704150, (01)00884838099258(21)2481, (01)00884838099272(21)580, (01)00884838099272(21)740, (01)00884838099258(21)2343, (01)00884838099258(21)3426, (01)00884838085268(21)1004, (01)00884838099272(21)1022, (01)00884838099272(21)207, (01)00884838054202(21)1703, (01)00884838085367(21)219, (01)00884838099272(21)598, (01)00884838085367(21)60, (01)00884838085268(21)546, (01)00884838099272(21)54, (01)00884838099272(21)849, (01)00884838099272(21)636, (01)00884838085367(21)398, (01)00884838116801(21)123, (01)00884838099272(21)82, (01)00884838059054(21)2406, (01)00884838099272(21)417, (01)00884838116801(21)23, (01)00884838116801(21)338, (01)00884838085367(21)96, (01)00884838116801(21)181, (01)00884838054226(21)146, (01)00884838099272(21)152, (01)00884838099272(21)385, (01)00884838099258(21)3340, (01)00884838099258(21)774, (01)00884838099258(21)3266, (01)00884838099272(21)305, (01)00884838099258(21)2164, (01)00884838099272(21)832, (01)00884838099272(21)1059, (01)00884838085268(21)72, (01)00884838099272(21)1118, (01)00884838099272(21)867, (01)00884838116801(21)130, (01)00884838054202(21)113, (01)00884838085268(21)764, (01)00884838085268(21)1188, (01)00884838099272(21)627, (01)00884838059115(21)343, (01)00884838099272(21)872, (01)00884838099272(21)1080, (01)00884838054226(21)154, (01)00884838085367(21)346, (01)00884838099272(21)6, (01)00884838116771(21)596, (01)00884838116801(21)279, (01)00884838116771(21)677, (01)00884838099272(21)1035, (01)00884838099258(21)3321, (01)00884838099272(21)791, (01)00884838059115(21)291, (01)00884838085367(21)49, (01)00884838085367(21)286, (01)00884838085268(21)775, (01)00884838085268(21)1139, , (01)00884838059115(21)104, (01)00884838059115(21)105, (01)00884838099272(21)772, (01)00884838059115(21)145, (01)00884838099272(21)1093, (01)00884838099272(21)7, (01)00884838116801(21)128, (01)00884838116801(21)86, (01)00884838099258(21)1951, (01)00884838116801(21)94, (01)00884838099272(21)664, (01)00884838116771(21)58, (01)00884838099258(21)2232, (01)00884838059115(21)103, (01)00884838099272(21)52, (01)00884838099272(21)53, (01)00884838099258(21)2214, (01)00884838116771(21)127, (01)00884838054226(21)66, (01)00884838085367(21)102, (01)00884838099272(21)890, , (01)00884838116771(21)360, (01)00884838085367(21)124, (01)00884838099258(21)2455, (01)00884838059115(21)188, (01)00884838116801(21)82, (01)00884838116801(21)268, (01)00884838085367(21)362, (01)00884838059115(21)350, (01)00884838116771(21)52, (01)00884838059115(21)422, (01)00884838099272(21)729, (01)00884838116801(21)277, (01)00884838099272(21)478, (01)00884838099258(21)1852, (01)00884838099272(21)650, (01)00884838099272(21)26, (01)00884838099258(21)724, (01)00884838099272(21)883, (01)00884838085367(21)145, (01)00884838099272(21)453, (01)00884838099272(21)889, (01)00884838099258(21)1431, (01)00884838085367(21)299, (01)00884838099258(21)3749, (01)00884838099258(21)2006, (01)00884838085268(21)1336, (01)00884838099258(21)2440, (01)00884838085268(21)703339, (01)00884838085268(21)1091, (01)00884838099272(21)673, (01)00884838054226(21)50, (01)00884838099272(21)844, (01)00884838054202(21)1062, (01)00884838099258(21)2342, (01)00884838085268(21)1024, (01)00884838099234(21)688, (01)00884838099258(21)2909, (01)00884838099272(21)276, (01)00884838085268(21)1092, (01)00884838085268(21)703484, (01)00884838054202(21)1557, (01)00884838099234(21)637, (01)00884838099272(21)69, (01)00884838059115(21)43, (01)00884838085367(21)187, (01)00884838085367(21)183, (01)00884838116801(21)111, (01)00884838116801(21)172, (01)00884838116801(21)112, (01)00884838099272(21)528, (01)00884838099272(21)660, (01)00884838099272(21)74, (01)00884838099272(21)855, (01)00884838059115(21)237, (01)00884838059115(21)230, (01)00884838085367(21)45, (01)00884838099272(21)286, (01)00884838099272(21)317, (01)00884838099258(21)556, (01)00884838099272(21)42, (01)00884838085367(21)331, (01)00884838116801(21)259, (01)00884838099272(21)229, (01)00884838059115(21)247, (01)00884838099272(21)908, (01)00884838085367(21)106, (01)00884838116801(21)103, (01)00884838059115(21)116, (01)00884838059115(21)242, (01)00884838099258(21)280, (01)00884838099258(21)646, (01)00884838059115(21)29, (01)00884838116801(21)52, (01)00884838085367(21)112, (01)00884838099258(21)3185, (01)00884838085367(21)501, (01)00884838099258(21)917, (01)00884838085367(21)393, (01)00884838085367(21)116, (01)00884838059115(21)276, (01)00884838099272(21)540, (01)00884838085268(21)614, (01)00884838099258(21)568, (01)00884838099272(21)73, (01)00884838099272(21)405, (01)00884838085367(21)139, (01)00884838099272(21)583, (01)00884838099272(21)784, (01)00884838099272(21)525, (01)00884838099272(21)312, (01)00884838085367(21)122, (01)00884838116801(21)80, (01)00884838116801(21)175, (01)00884838099272(21)658, (01)00884838099272(21)216, (01)00884838099272(21)95, (01)00884838059061(21)542, (01)00884838099272(21)39, (01)00884838099272(21)856, (01)00884838116801(21)305, (01)00884838099272(21)853, (01)00884838099272(21)653, (01)00884838099258(21)2642, (01)00884838099272(21)502, (01)00884838116801(21)92, (01)00884838099272(21)70, (01)00884838099272(21)128, (01)00884838099272(21)287, (01)00884838099272(21)89, (01)00884838099272(21)807, (01)00884838099272(21)265, (01)00884838059115(21)179, (01)00884838099272(21)304, (01)00884838116801(21)155, (01)00884838085367(21)390, (01)00884838099272(21)110, (01)00884838059115(21)303, (01)00884838085367(21)300, (01)00884838085367(21)67, (01)00884838099272(21)841, (01)00884838059061(21)182, (01)00884838085367(21)61, (01)00884838085367(21)157, (01)00884838099272(21)234, (01)00884838099272(21)885, (01)00884838085367(21)154, (01)00884838099272(21)64, (01)00884838085367(21)100, (01)00884838099272(21)916, (01)00884838085367(21)217, (01)00884838099272(21)192, (01)00884838099272(21)193, (01)00884838059115(21)245, (01)00884838099272(21)618, (01)00884838099272(21)32, (01)00884838099272(21)206, (01)00884838099272(21)904, (01)00884838059115(21)41, (01)00884838099272(21)49, (01)00884838099272(21)541, (01)00884838116801(21)85, (01)00884838059115(21)234, (01)00884838099272(21)646, (01)00884838099272(21)870, (01)00884838099272(21)258, (01)00884838099272(21)172, (01)00884838099272(21)529, (01)00884838059115(21)208, (01)00884838059061(21)563, (01)00884838059115(21)193, (01)00884838099272(21)524, (01)00884838116801(21)142, (01)00884838085367(21)379, (01)00884838085268(21)703357, (01)00884838099258(21)197, (01)00884838099272(21)33, (01)00884838116801(21)105, (01)00884838099272(21)656, (01)00884838059115(21)266, (01)00884838099272(21)290, (01)00884838085367(21)202, (01)00884838116771(21)20, (01)00884838085367(21)226, (01)00884838059061(21)436, (01)00884838054219(21)44, (01)00884838085367(21)464, (01)00884838116801(21)108, (01)00884838116801(21)53, (01)00884838116801(21)144, (01)00884838059061(21)406, (01)00884838099272(21)163, (01)00884838099272(21)852, (01)00884838116801(21)198, (01)00884838116801(21)124, (01)00884838099272(21)62, (01)00884838085367(21)274, (01)00884838099272(21)1034, (01)00884838085367(21)163, (01)00884838085367(21)186, (01)00884838059115(21)195, (01)00884838099272(21)806, (01)00884838099272(21)210, (01)00884838085367(21)260, (01)00884838085367(21)502, (01)00884838059115(21)330, (01)00884838059061(21)395, (01)00884838099258(21)1582, (01)00884838085367(21)498, (01)00884838059061(21)458, (01)00884838116801(21)261, (01)00884838099272(21)847, (01)00884838085367(21)156, (01)00884838116801(21)109, (01)00884838099272(21)587, (01)00884838099272(21)154, (01)00884838116801(21)83, (01)00884838099272(21)186, , (01)00884838116801(21)171, (01)00884838099258(21)3451, (01)00884838054240(21)173, (01)00884838059115(21)187, (01)00884838099272(21)425, (01)00884838116801(21)76, (01)00884838085367(21)208, (01)00884838099258(21)1400, (01)00884838099272(21)500, (01)00884838059115(21)79, (01)00884838116801(21)106, (01)00884838054240(21)64, (01)00884838099272(21)537, (01)00884838085367(21)430, (01)00884838085367(21)161, (01)00884838099258(21)910, (01)00884838116801(21)49, (01)00884838099272(21)375, (01)00884838116801(21)77, (01)00884838099272(21)567, (01)00884838099272(21)479, (01)00884838059115(21)361, (01)00884838085367(21)155, (01)00884838099272(21)31, (01)00884838085268(21)294, (01)00884838099272(21)302, (01)00884838054226(21)170, (01)00884838059061(21)535, (01)00884838099272(21)406, (01)00884838099272(21)857, (01)00884838054219(21)89, (01)00884838059115(21)284, (01)00884838059115(21)21, (01)00884838085367(21)191, (01)00884838099272(21)770, (01)00884838116801(21)78, (01)00884838099272(21)56, (01)00884838059061(21)344, (01)00884838099258(21)718, (01)00884838059115(21)64, (01)00884838085367(21)94, (01)00884838099272(21)155, (01)00884838099272(21)177, (01)00884838085367(21)66, (01)00884838099272(21)96, (01)00884838099272(21)28, (01)00884838099272(21)560, (01)00884838099272(21)433, (01)00884838085367(21)108, (01)00884838085367(21)200, (01)00884838085367(21)201, (01)00884838099272(21)324, (01)00884838085367(21)189, (01)00884838116801(21)59, (01)00884838059122(21)2, (01)00884838059061(21)522, (01)00884838099272(21)588, (01)00884838085367(21)311, (01)00884838059115(21)272, (01)00884838059115(21)210, (01)00884838116801(21)104, (01)00884838059115(21)243, (01)00884838099272(21)79, (01)00884838116801(21)107, (01)00884838059061(21)394, (01)00884838099272(21)236, (01)00884838059115(21)20, (01)00884838099272(21)863, (01)00884838116801(21)152, (01)00884838099272(21)165, (01)00884838099272(21)402, (01)00884838099272(21)652, (01)00884838085367(21)297, (01)00884838116801(21)153, (01)00884838099272(21)241, (01)00884838059115(21)218. AneurysmFlow is a software medical device intended to be used in combination with the Philips interventional X-ray system (Allura and Azurion systems) and 3DRA data. The Allura and Azurion systems are not impacted by this recall. Since AneurysmFlow is always used with Allura and Azurion systems, below is information of those systems that are currently being used with the affected software to help with identification of the affected devices. The Allura and Azurion model numbers where AneurysmFlow is used are the following: 722006, 722008, 722012, 722013, 722015, 722028, 722068, 722029, 722035, 722038, 722079, 722058, 722226, 722236, 722059, 722224, 722234, 722228, 722282.

Quantity Affected: 1,033 units

Reason for Recall

Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-19

Company