PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system; System Code Description (Model Numbers): Allu

Hazard / Issue

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, 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(01)00884838059030(21)319, (01)00884838059030(21)1223, (01)00884838059030(21)1252, (01)00884838059030(21)739, (01)00884838059030(21)1380, (01)00884838059030(21)1023, (01)00884838059030(21)1019, (01)00884838059030(21)541, (01)00884838059030(21)731, (01)00884838059030(21)1215, (01)00884838059030(21)247, (01)00884838059030(21)1191, (01)00884838059030(21)856, (01)00884838059030(21)1375, (01)00884838059030(21)1350, (01)00884838059030(21)971, (01)00884838059030(21)356, (01)00884838059030(21)877, (01)00884838059030(21)164, (01)00884838059030(21)1125, (01)00884838059030(21)960, (01)00884838059030(21)272, (01)00884838059030(21)1426, (01)00884838059030(21)989, (01)00884838059030(21)340, (01)00884838059030(21)35, (01)00884838059030(21)34, (01)00884838059030(21)1196, (01)00884838059030(21)249, (01)00884838059030(21)1294, (01)00884838059030(21)114, (01)00884838059030(21)80, (01)00884838059030(21)1445, (01)00884838059030(21)380, (01)00884838059030(21)1276, (01)00884838059030(21)935, (01)00884838059030(21)1242, (01)00884838059030(21)224, (01)00884838059030(21)106, (01)00884838059030(21)104, (01)00884838059030(21)1401, (01)00884838059030(21)622, (01)00884838059030(21)371, (01)00884838059030(21)162, (01)00884838059030(21)333, (01)00884838059030(21)927, (01)00884838059030(21)1022, (01)00884838059030(21)1000, (01)00884838059030(21)930, (01)00884838059030(21)1197, (01)00884838059030(21)1116, (01)00884838059030(21)903, (01)00884838059030(21)1435, (01)00884838059030(21)91, (01)00884838059030(21)1346, (01)00884838059030(21)602, (01)00884838059030(21)245, (01)00884838059030(21)535, (01)00884838059030(21)941, (01)00884838059030(21)232, (01)00884838059030(21)230, (01)00884838059030(21)991, (01)00884838059030(21)231, (01)00884838059030(21)248, (01)00884838059030(21)1111, (01)00884838059030(21)1029, (01)00884838059030(21)742, (01)00884838059030(21)222, (01)00884838059030(21)797, (01)00884838059030(21)254, (01)00884838059030(21)416, (01)00884838059030(21)1010, (01)00884838059030(21)687, (01)00884838059030(21)1304, (01)00884838059030(21)502, (01)00884838059030(21)1124, (01)00884838059030(21)174, (01)00884838059030(21)537, (01)00884838059030(21)1199, (01)00884838059030(21)1339, (01)00884838059030(21)1001, (01)00884838059030(21)1351, (01)00884838059030(21)1307, (01)00884838059030(21)134, (01)00884838059030(21)1137, (01)00884838059030(21)483, (01)00884838059030(21)1068, (01)00884838059030(21)760, (01)00884838059030(21)1008, (01)00884838059030(21)1213, (01)00884838059030(21)1092, (01)00884838059030(21)1151, (01)00884838059030(21)1083, (01)00884838059030(21)1268, (01)00884838059030(21)955, (01)00884838059030(21)711, (01)00884838059030(21)1145, (01)00884838059030(21)514, (01)00884838059030(21)1273, (01)00884838059030(21)66, (01)00884838059030(21)1157, (01)00884838059030(21)1119, (01)00884838059030(21)702, (01)00884838059030(21)860, (01)00884838059030(21)685, (01)00884838059030(21)686, (01)00884838059030(21)942, (01)00884838059030(21)357, (01)00884838059030(21)1190, (01)00884838059030(21)961, (01)00884838059030(21)287, (01)00884838059030(21)948, (01)00884838059030(21)509, (01)00884838059030(21)619, (01)00884838059030(21)185, (01)00884838059030(21)1104, (01)00884838059030(21)887, (01)00884838059030(21)394, (01)00884838059030(21)304, (01)00884838059030(21)863, (01)00884838059030(21)799, (01)00884838059030(21)1224, (01)00884838059030(21)1225, (01)00884838059030(21)1021, (01)00884838059030(21)1422, (01)00884838059030(21)1033, (01)00884838059030(21)1136, (01)00884838059030(21)998, (01)00884838059030(21)834, (01)00884838059030(21)1150, (01)00884838059030(21)1091, (01)00884838059030(21)832, (01)00884838059030(21)311, (01)00884838059030(21)142, (01)00884838059030(21)388, (01)00884838059030(21)599, (01)00884838059030(21)1188, (01)00884838059030(21)235, (01)00884838059030(21)236, (01)00884838059030(21)1030, (01)00884838059030(21)1031, (01)00884838059030(21)956, (01)00884838059030(21)850, (01)00884838059030(21)250, (01)00884838059030(21)1097, (01)00884838059030(21)904, (01)00884838059030(21)199, (01)00884838059030(21)328, (01)00884838059030(21)182, (01)00884838059030(21)294, (01)00884838059030(21)103, (01)00884838059030(21)77, (01)00884838059030(21)122, (01)00884838059030(21)810, (01)00884838059030(21)184, (01)00884838059030(21)474, (01)00884838059030(21)471, (01)00884838059030(21)962, (01)00884838059030(21)138, (01)00884838059030(21)1182, (01)00884838059030(21)1090, (01)00884838059030(21)549, (01)00884838059030(21)1065, (01)00884838059030(21)1376, (01)00884838059030(21)1433, (01)00884838059030(21)1355, (01)00884838059030(21)689, (01)00884838059030(21)163, (01)00884838059030(21)631, (01)00884838059030(21)1303, (01)00884838059030(21)1155, (01)00884838059030(21)558, (01)00884838059030(21)804, (01)00884838059030(21)1044, (01)00884838059030(21)822, (01)00884838059030(21)852, (01)00884838059030(21)880, (01)00884838059030(21)476, (01)00884838059030(21)862, (01)00884838059030(21)1280, (01)00884838059030(21)1300, (01)00884838059030(21)858, (01)00884838059030(21)362, (01)00884838059030(21)1207, (01)00884838059030(21)1076, (01)00884838059030(21)874, (01)00884838059030(21)1218, (01)00884838059030(21)1313, (01)00884838059030(21)710, (01)00884838059030(21)934, (01)00884838059030(21)645, (01)00884838059030(21)855, (01)00884838059030(21)583, (01)00884838059030(21)94; 3. Allura Xper FD10; Model: 722026; UDI: (01)00884838054189(21)683, (01)00884838054189(21)155, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054189(21)786, (01)00884838054189(21)654, (01)00884838054189(21)1132, (01)00884838054189(21)458, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054189(21)436, (01)00884838054189(21)1338, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054189(21)78, (01)00884838054189(21)432, (01)00884838054189(21)224, (01)00884838054189(21)1072, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)543, (01)00884838054189(21)1248, (01)00884838054189(21)561, (01)00884838054189(21)1129, (01)00884838054189(21)781, (01)00884838054189(21)344, (01)00884838054189(21)374, (01)00884838054189(21)634, (01)00884838054189(21)908, (01)00884838054189(21)130, (01)00884838054189(21)370, (01)00884838054189(21)235, (01)00884838054189(21)190, (01)00884838054189(21)259, 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(01)00884838054189(21)192, (01)00884838054189(21)959, (01)00884838054189(21)825, (01)00884838054189(21)942, (01)00884838054189(21)1192, (01)00884838054189(21)990, (01)00884838054189(21)381, (01)00884838054189(21)774, (01)00884838054189(21)368, (01)00884838054189(21)245, (01)00884838054189(21)485, (01)00884838054189(21)484, (01)00884838054189(21)648, (01)00884838054189(21)966, (01)00884838054189(21)1268, (01)00884838054189(21)109, (01)00884838054189(21)110, (01)00884838054189(21)116, (01)00884838054189(21)604, (01)00884838054189(21)627, (01)00884838054189(21)319, (01)00884838054189(21)716, (01)00884838054189(21)396, (01)00884838054189(21)531, (01)00884838054189(21)156, (01)00884838054189(21)253, (01)00884838054189(21)965, (01)00884838054189(21)444, (01)00884838054189(21)1189, (01)00884838054189(21)1126, (01)00884838054189(21)1210, (01)00884838054189(21)1239, (01)00884838054189(21)102, (01)00884838054189(21)1215, (01)00884838054189(21)696, (01)00884838054189(21)560, (01)00884838054189(21)297, (01)00884838054189(21)562, (01)00884838054189(21)11, (01)00884838054189(21)832, (01)00884838054189(21)335, (01)00884838054189(21)664, (01)00884838054189(21)845, (01)00884838054189(21)778, (01)00884838054189(21)215, (01)00884838054189(21)935, (01)00884838054189(21)782, (01)00884838054189(21)614, (01)00884838054189(21)222, (01)00884838054189(21)205, (01)00884838054189(21)284, (01)00884838054189(21)115, (01)00884838054189(21)694, (01)00884838054189(21)74, (01)00884838054189(21)838, (01)00884838054189(21)244, (01)00884838054189(21)973, (01)00884838054189(21)985, (01)00884838054189(21)101, (01)00884838054189(21)855, (01)00884838054189(21)287, (01)00884838054189(21)378, (01)00884838054189(21)612, (01)00884838054189(21)725, (01)00884838054189(21)914, (01)00884838054189(21)805, (01)00884838054189(21)622, (01)00884838054189(21)234, (01)00884838054189(21)1293, (01)00884838054189(21)121, (01)00884838054189(21)512, (01)00884838054189(21)559, (01)00884838054189(21)1205, (01)00884838054189(21)79, (01)00884838054189(21)617, (01)00884838054189(21)1101, (01)00884838054189(21)738, (01)00884838054189(21)957, (01)00884838054189(21)431, (01)00884838054189(21)201, (01)00884838054189(21)1340, (01)00884838054189(21)122, (01)00884838054189(21)663, (01)00884838054189(21)653, (01)00884838054189(21)688, (01)00884838054189(21)563, (01)00884838054189(21)704, (01)00884838054189(21)462, (01)00884838054189(21)191, (01)00884838054189(21)931, (01)00884838054189(21)967, (01)00884838054189(21)265, (01)00884838054189(21)998, (01)00884838054189(21)986, (01)00884838054189(21)534, (01)00884838054189(21)807, (01)00884838054189(21)962, (01)00884838054189(21)961, (01)00884838054189(21)1049, (01)00884838054189(21)707, (01)00884838054189(21)866, (01)00884838054189(21)1115, (01)00884838054189(21)759, (01)00884838054189(21)830, (01)00884838054189(21)638, (01)00884838054189(21)271, (01)00884838054189(21)813, (01)00884838054189(21)775, (01)00884838054189(21)1316, 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