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Moderate riskFDA DeviceClass II

Philips Azurion 7 M12 X-ray system recalled for foot switch imaging failure

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 M12 X-ray imaging systems. When using the foot switch, X-ray imaging may not start or may start and stop intermittently. This affects approximately 1,994 systems sold worldwide, including 360 in the U.S.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Contact Philips Medical Systems if you operate an Azurion 7 M12 system to verify whether your serial number is affected
  2. Do not rely on the wired foot switch until you receive guidance from Philips
  3. Follow any instructions or updates from Philips regarding a fix or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
1994 units (360 US, 1634 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1677-2026

In the FDA's words

Description
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (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,
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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