PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

Hazard / Issue

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: (1) System Code: 722078; UDI: 00884838085251; System Serial Number: 302, 585, 410, 753, 523, 293, 840, 291, 536, 537, 870, 613, 598, 679, 224, 829, 249, 546, 478, 479, 513, 278, 437, 438, 456, 566, 833, 488, 327, 550, 571, 544, 545, 465, 376, 31, 921, 700, 165, 445, 539, 654, 656, 657, 658, 436, 1007, 862, 786, 308, 396, 576, 121, 239, 383, 491, 125, 500, 645, 379, 399, 803, 415, 296, 136, 890, 626, 697, 559, 532, 538, 185, 166, 257, 258, 684, 359, 143, 661, 824, 649, 493, 720, 520, 521, 556, 557, 558, 187, 902, 269, 317, 522, 611, 677, 709, 535, 170, 723, 251, 298, 22, 305, 725, 728, 524, 290, 441, 384, 480, 481, 364, 294, 906, 240, 256, 603, 289, 719, 163, 215, 271, 788, 412, 627, 141, 644, 292, 844, 876, 748, 483, 497, 309, 232, 425, 635, 612, 797, 247, 733, 162, 517, 888, 923, 204, 205, 206, 195, 197, 218, 444, 986, 561, 503, 689, 499, 135, 589, 38, 977, 738, 476, 380, 453, 24, 690, 356, 343, 344, 174, 898, 482, 378, 764, 693, 694, 770, 771, 772, 773, 439, 191, 938, 980, 981, 982, 307, 628, 235, 139, 178, 179, 265, 266, 511, 526, 746, 264, 287, 361, 362, 1003, 348, 897, 845, 960, 1036, 967, 374, 375, 564, 142, 469, 934, 565, 835, 836, 929, 975, 681, 1069, 1070, 1071, 1072, 893, 1061, 382, 324, 604, 713, 114, 849, 326, 659, 346, 347, 26, 621, 553, 325, 648, 1058, 1068, 339, 340, 414, 687, 688, 237, 958, 751, 881, 698, 610, 20, 846, 625, 424, 800, 838, 590, 150, 762, 485, 726, 727, 1039, 847, 959, 962, 865, 180, 371, 769, 570, 572, 1031, 792, 702, 196, 28, 29, 683, 541, 213, 320, 1025, 943, 651, 722, 242, 36, 431, 672, 177, 578, 912, 355, 504, 699, 270, 306, 190, 366, 52, 398, 470, 562, 489, 147, 160, 743, 152, 759, 630, 729, 151, 334, 815, 429, 449, 757, 506, 703, 149, 818, 647, 419, 328, 584, 223, 192, 779, 468, 222, 200, 134, 262, 855, 284, 918, 919, 277, 976, 13, 15, 502, 817, 795, 498, 574, 577, 254, 255, 448, 27, 631, 632, 599, 370, 216, 451, 428, 467, 450, 102, 662, 189, 633, 512, 175, 796, 459, 460, 718, 462, 464, 891, 768, 263, 944, 669, 112, 23, 452, 338, 367, 440, 490, 181, 145, 250, 705, 49, 50, 51, 617, 336, 226, 761, 220, 221, 1037, 799, 839, 354, 153, 154, 957, 471, 357, 130, 132, 133, 261, 695, 158, 507, 854, 477, 785, 789, 404, 877, 806, 422, 194, 801, 802, 140, 608, 878, 952, 10, 123, 319, 686, 805, 397, 127, 128, 253, 594, 988, 300, 301, 321, 332, 35, 17, 341, 563, 314, 316, 496, 641, 953, 30, 950, 331, 652, 1005, 349, 236, 979, 831, 501, 841, 842, 905, 682, 843, 830, 323, 315, 680, 365, 282, 283, 602, 203, 202, 40, 673, 674, 675, 676, 609, 295, 368, 369, 615, 618, 310, 199, 455, 668, 352, 193, 280, 667, 884, 567, 183, 749, 692, 32, 241, 935, 407, 408, 505, 138, 157, 752, 461, 463, 423, 554, 252, 169, 426, 650, 351, 442, 750, 968, 207, 208, 209, 210, 211, 622, 623, 629, 129, 529, 144, 400, 401, 411, 259, 457, 579, 926, 597, 899, 322, 978, 173, 418, 637, 670, 909, 601, 37, 1033, 1035, 227, 1009, 1008, 989, 984, 987, 907, 1081, 1004, 1086, 1084, 1085, 1048, 1059, 1034, 1080, 1015, 875, 1026, 1077, 716, 717, 1045, 940, 942, 945, 946, 947, 948, 1052, 971, 1062, 1063, 994, 701, 993, 620, 1075, 1046, 970, 985, 798, 1074, 856, 710, 1011, 1064, 1065, 1066, 1067, 1000, 1056, 992, 663, 1057, 964, 965, 1043, 735, 736, 819, 820, 272, 1049, 1073, 1079, 712, 714, 732, 774, 381, 233, 638, 318, 593, 624, 775, 776, 21, 267, 268, 487, 421, 760, 542, 614, 864, 148, 837, 458, 596, 377, 281, 784, 991, 528, 42, 44, 45, 41, 43, 466, 704, 219, 217, 260, 103, 430, 342, 126, 184, 778, 547, 586, 879, 159, 363, 896, 642, 472, 39, 172, 782, 961, 33, 643, 581, 552, 525, 311, 312, 510, 857, 731, 432, 433, 636, 954, 447, 333, 358, 540, 619, 492, 527, 600, 816, 434, 892, 990, 124, 122, 146, 201, 509, 495, 515, 353, 303, 304, 186, 286, 548, 518, 486, 474, 475, 1047, 853, 243, 244, 335, 549, 46, 616, 972, 533, 777, 182, 1032, 1051, 850, 696, 345, 575, 939, 869, 874, 871, 1010, 1029, 1030, 18, 551, 1013, 917, 543, 516, 12, 416, 155, 446, 685, 715, 225, 1082, 913, 582, 908, 19, 435, 16, 11, 167, 664, 901, 508, 530, 198; (2) System Code: 722223; UDI: 00884838099241; System Serial Number: 312, 324, 332, 585, 85, 533, 189, 479, 1038, 47, 1146, 352, 391, 328, 681, 1052, 1130, 388, 581, 855, 905, 570, 77, 448, 495, 571, 171, 1051, 439, 126, 628, 36, 1088, 580, 1179, 1241, 1065, 799, 577, 1060, 1107, 1114, 323, 252, 626, 261, 207, 329, 1001, 801, 560, 561, 205, 379, 440, 204, 192, 197, 177, 37, 340, 1097, 282, 357, 1015, 214, 44, 206, 210, 336, 1231, 343, 365, 390, 1067, 1106, 1144, 186, 187, 631, 87, 373, 514, 599, 601, 602, 69, 638, 728, 937, 944, 945, 951, 852, 256, 679, 596, 67, 932, 503, 432, 131, 301, 456, 704, 659, 242, 746, 1161, 1090, 1265, 455, 457, 221, 454, 829, 816, 318, 229, 230, 262, 308, 637, 124, 198, 433, 883, 889, 566, 1084, 880, 665, 188, 367, 52, 371, 892, 127, 105, 572, 104, 334, 627, 458, 1113, 463, 487, 470, 96, 277, 616, 1140, 211, 850, 223, 1242, 872, 877, 97, 1211, 161, 1132, 386, 1123, 208, 1061, 361, 258, 597, 727, 1008, 1296, 180, 1181, 835, 668, 377, 882, 565, 1103, 196, 130, 1185, 1150, 886, 887, 452, 453, 269, 888, 1188, 567, 966, 449, 435, 441, 669, 351, 508, 750, 164, 139, 355, 619, 1236, 133, 89, 370, 598, 714, 119, 1306, 1307, 871, 697, 698, 1035, 1036, 116, 154, 100, 912, 99, 349, 387, 136, 775, 903, 867, 680, 527, 1227, 629, 1264, 834, 1226, 155, 837, 17, 18, 804, 235, 249, 477, 1025, 1177, 1153, 1210, 167, 1290, 1293, 227, 965, 999, 46, 1131, 141, 1282, 1005, 1129, 1115, 237, 348, 287, 1325, 135, 414, 416, 417, 132, 814, 836, 1245, 356, 809, 810, 303, 1214, 1099, 813, 1167, 1232, 1248, 322, 587, 591, 812, 875, 904, 756, 516, 917, 1016, 10, 1256, 537, 582, 694, 1055, 576, 134, 247, 961, 963, 1222, 1217, 1272, 584, 7, 923, 933, 709, 193, 128, 393, 434, 615, 1165, 854, 550, 657, 1283, 1196, 1258, 407, 1212, 612, 926, 353, 398, 555, 848, 931, 213, 364, 909, 910, 918, 916, 265, 1243, 142, 168, 518, 476, 671, 683, 302, 863, 864, 1033, 894, 25, 1295, 482, 919, 693, 553, 1191, 868, 114, 191, 409, 106, 506, 232, 446, 403, 1125, 823, 670, 803, 1284, 1253, 1254, 579, 289, 703, 705, 311, 776, 1104, 719, 480, 113, 609, 822, 1095, 1137, 1042, 1043, 1078, 519, 521, 520, 522, 523, 524, 525, 526, 858, 362, 375, 747, 272, 81, 661, 723, 821, 862, 140, 761, 63, 109, 1003, 1251, 1041, 1271, 998, 316, 317, 78, 978, 202, 1276, 824, 915, 711, 108, 185, 754, 928, 846, 847, 893, 1262, 1263, 769, 755, 906, 313, 314, 238, 239, 1034, 430, 299, 1247, 363, 40, 574, 486, 354, 710, 279, 280, 281, 845, 960, 306, 992, 989, 618, 225, 226, 173, 212, 8, 9, 157, 165, 344, 1147, 431, 590, 1083, 492, 28, 274, 753, 424, 425, 817, 820, 1237, 818, 819, 1207, 1301, 405, 974, 975, 976, 635, 924, 217, 381, 395, 111, 691, 815, 436, 437, 438, 35, 830, 938, 331, 1010, 1011, 79, 1267, 295, 65, 234, 1246, 796, 337, 1075, 270, 468, 376, 450, 451, 49, 505, 650, 1059, 1259, 1050, 465, 68, 636, 20, 383, 245, 246, 1261, 222, 374, 930, 793, 794, 795, 849, 712, 861, 1291, 325, 907, 908, 859, 605, 61, 544, 1289, 1285, 851, 1201, 921, 589, 1100, 273, 294, 800, 806, 333, 4, 118, 1195, 1197, 1135, 429, 264, 720, 707, 606, 43, 392, 418, 759, 1280, 179, 445, 215, 556, 1027, 21, 442, 791, 807, 76, 922, 1275, 427, 257, 266, 1268, 1336, 228, 460, 554, 194, 954, 956, 174, 1151, 684, 558, 559, 563, 564, 724, 1077, 702, 1092, 48, 779, 422, 583, 573, 413, 995, 541, 600, 183, 6, 1190, 699, 700, 701, 664, 876, 419, 666, 12, 243, 1017, 1037, 283, 1286, 30, 502, 790, 22, 778, 1117, 1239, 540, 169, 485, 26, 787, 507, 396, 382, 176, 986, 685, 682, 1141, 721, 91, 378, 773, 640, 641, 1021, 805, 304, 443, 562, 115, 259, 985, 159, 160, 994, 1186, 170, 82, 199, 271, 988, 481, 828, 860, 278, 219, 461, 549, 802, 66, 298, 552, 285, 497, 962, 534, 1073, 613, 1250, 1270, 1335, 611, 1122, 1124, 692, 766, 996, 997, 652, 900, 614, 517, 1172, 990, 991, 1176, 1310, 957, 780, 781, 1304, 686, 687, 688, 689, 1287, 1288, 1332, 1171, 634, 1198, 979, 1334, 843, 651, 678, 1317, 782, 987, 798, 825, 797, 1302, 1128, 604, 1321, 1322, 935, 838, 1218, 1225, 811, 1328, 762, 758, 1057, 1330, 763, 764, 765, 767, 953, 644, 1169, 1228, 421, 655, 662, 873, 874, 92, 1133, 1136, 632, 792, 218, 784, 760, 535, 542, 543, 895, 426, 1160, 117, 195, 255, 42, 839, 708, 536, 254, 1108, 41, 914, 359, 360, 408, 1019, 642, 90, 643, 286, 288, 290, 72, 74, 80, 1184, 955, 1063, 423, 706, 1252, 291, 483, 1007, 241, 625, 656, 751, 774, 630, 531, 939, 941, 1024, 478, 1143, 645, 646, 647, 648, 786, 660, 2, 840, 24, 674, 358, 1079, 110, 649, 102, 315, 1109, 1235, 38, 673, 1066, 925, 940, 934, 201, 1229, 121, 122, 1189, 902, 1116, 123, 34, 1206, 250, 64, 172, 369, 175, 1298, 1056, 490, 1013, 1014, 1026, 832, 578, 473, 138, 462, 841, 842, 1159, 808, 305, 530, 1074, 474, 475, 515, 620, 768, 857, 913, 103, 27, 603, 1158, 623, 968, 983, 1009, 993, 972, 1199, 1230, 1257, 267, 268, 1209, 293, 639, 1202, 182, 1040, 156, 158, 224, 163, 1157, 389, 1216, 510, 958, 1039, 1081, 444, 1192, 1238, 1045, 83, 491, 420, 1233, 969, 967, 952, 1023, 512, 569, 610, 1030, 551, 1012, 410, 1044, 330, 896, 1178, 251, 406, 404, 1004, 86, 397, 33, 748, 547, 1000, 399, 400, 366, 1018, 513, 345, 380, 94, 621, 95, 13, 428, 672, 1200, 977, 927, 1119, 1120, 1029, 190, 1208, 879, 901, 1224, 296, 297, 263, 342, 539, 726, 494, 1260, 319, 320, 586, 300, 276, 493, 624, 1111, 292, 368, 777, 84, 788, 789, 184, 338, 467, 107, 166, 1193, 898, 622, 1062, 1082, 1053, 200, 509, 532, 653, 1096, 695, 592, 884, 633, 327, 749, 394, 1215, 943, 971; (3) System Code: 722233; UDI: 00884838116764; System Serial Number: 64, 122, 169, 170, 267, 96, 144, 212, 153, 259, 118, 214, 41, 59, 124, 147, 103, 108, 111, 172, 127, 192, 218, 219, 250, 123, 37, 38, 183, 273, 304, 17, 137, 76, 300, 12, 201, 238, 82, 288, 295, 297, 298, 8, 141, 26, 27, 235, 68, 14, 138, 139, 117, 279, 58, 240, 28, 7, 280, 281, 31, 165, 166, 62, 100, 95, 29, 200, 203, 204, 205, 120, 310, 285, 292, 161, 181, 110, 112, 173, 160, 51, 75, 202, 86, 197, 176, 223, 211, 136, 227, 81, 16, 24, 184, 129, 156, 222, 253, 30, 284, 134, 143, 233, 162, 71, 40, 48, 101, 180, 105, 106, 133, 57, 61, 186, 189, 89, 90, 91, 145, 44, 231, 268, 312, 85, 221, 193, 194, 83, 84, 87, 88, 19, 5, 6, 18, 178, 60, 257, 55, 239, 243, 130, 234, 9, 32, 159, 217, 260, 56, 20, 225, 291, 50, 11, 72, 107, 35, 46, 47, 74, 43, 104, 78, 290, 272, 249, 77, 80, 174, 163, 97, 102, 146, 148, 149, 109, 15, 13, 39, 206, 67;