Recall Weekly
Moderate riskFDA DeviceClass II

Philips Azurion 7 B20 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 B20 X-ray imaging systems. The foot switch may fail to start X-ray imaging or cause imaging to stop and restart intermittently during use. This affects approximately 1,500 units worldwide, including about 320 in the United States.

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

What to do

  1. Contact Philips Medical Systems immediately if you operate an Azurion 7 B20 system
  2. Do not rely on the wired foot switch until you receive instructions from Philips
  3. Check the system serial number on your device against the FDA recall notice to confirm if your unit is affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
1523 units (322 US, 1201 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1676-2026

In the FDA's words

Description
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; 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: 722068; UDI: 00884838085367; System Serial Number: 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590, 198, 600, 228, 380, 420, 397, 212, 475, 180, 268, 269, 414, 74, 562, 115, 349, 291, 519, 234, 219, 532, 533, 60, 398, 618, 549, 46, 96, 416, 249, 531, 426, 162, 290, 346, 49, 326, 286, 125, 102, 113, 124, 138, 362, 127, 145, 299, 317, 571, 187, 183, 45, 331, 106, 465, 281, 112, 501, 393, 116, 273, 188, 264, 139, 503, 122, 439, 135, 248, 404, 390, 263, 90, 300, 224, 67, 61, 157, 154, 100, 217, 253, 391, 144, 379, 202, 105, 226, 315, 464, 197, 63, 252, 175, 274, 163, 186, 260, 502, 152, 498, 156, 621, 296, 208, 430, 161, 436, 409, 155, 298, 191, 278, 368, 94, 66, 108, 200, 201, 98, 189, 311, 367, 297, 132, 507, 451; (2) System Code: 722226; UDI: 00884838099272; System Serial Number: 120, 122, 123, 124, 125, 126, 127, 153, 67, 209, 271, 675, 112, 1052, 1091, 113, 121, 139, 158, 1078, 1145, 239, 105, 678, 114, 362, 758, 403, 702, 108, 545, 197, 380, 281, 688, 592, 593, 495, 319, 687, 921, 182, 183, 325, 690, 100, 272, 680, 724, 350, 891, 280, 270, 254, 107, 144, 761, 681, 691, 779, 294, 845, 559, 116, 343, 98, 301, 117, 876, 1021, 244, 332, 781, 782, 534, 341, 374, 78, 11, 441, 129, 180, 918, 442, 220, 555, 189, 190, 871, 446, 842, 255, 848, 208, 554, 955, 360, 337, 159, 400, 757, 326, 323, 175, 427, 464, 468, 778, 683, 143, 262, 482, 971, 391, 392, 173, 793, 147, 204, 467, 1017, 260, 381, 912, 410, 508, 419, 313, 472, 894, 318, 473, 383, 689, 973, 463, 823, 181, 205, 361, 59, 756, 379, 1008, 266, 1002, 398, 75, 786, 19, 1125, 213, 214, 215, 1007, 814, 969, 970, 469, 219, 462, 296, 149, 704, 573, 458, 987, 141, 711, 693, 510, 882, 226, 509, 584, 21, 1050, 647, 225, 201, 202, 303, 666, 184, 243, 178, 179, 250, 1139, 674, 1062, 575, 1121, 368, 950, 861, 176, 712, 829, 413, 997, 249, 589, 1046, 708, 738, 1083, 717, 697, 1126, 665, 416, 386, 764, 977, 595, 859, 1113, 721, 1043, 797, 957, 1006, 498, 60, 232, 423, 682, 789, 698, 331, 1097, 1094, 378, 808, 1107, 393, 949, 718, 663, 195, 411, 1092, 412, 715, 1143, 775, 1073, 982, 282, 785, 617, 958, 221, 222, 604, 430, 1027, 1067, 415, 810, 1114, 61, 1147, 314, 822, 561, 1026, 1102, 762, 306, 359, 978, 1060, 972, 83, 199, 1013, 920, 1136, 898, 835, 836, 795, 671, 799, 800, 899, 905, 838, 944, 1123, 335, 363, 1039, 731, 399, 869, 725, 701, 626, 967, 623, 744, 501, 953, 1018, 513, 533, 677, 449, 119, 367, 927, 480, 732, 974, 344, 824, 984, 487, 919, 605, 230, 523, 686, 327, 1138, 424, 684, 477, 1049, 298, 809, 10, 227, 520, 521, 522, 993, 874, 259, 140, 628, 530, 506, 909, 142, 733, 263, 490, 494, 633, 634, 396, 547, 631, 514, 642, 505, 321, 754, 17, 422, 1057, 420, 247, 99, 36, 432, 539, 88, 245, 911, 132, 133, 667, 5, 1103, 188, 586, 14, 622, 228, 4, 1069, 45, 316, 164, 485, 448, 507, 97, 351, 497, 685, 771, 790, 1076, 543, 66, 542, 550, 551, 484, 504, 714, 1054, 366, 18, 1048, 893, 1132, 217, 752, 1088, 47, 544, 148, 408, 906, 289, 548, 238, 299, 283, 284, 401, 404, 827, 833, 84, 692, 895, 118, 924, 224, 233, 1087, 579, 515, 455, 946, 599, 726, 676, 395, 670, 1, 261, 444, 826, 93, 956, 1077, 900, 901, 320, 355, 710, 435, 1072, 820, 749, 235, 846, 727, 621, 1129, 1041, 777, 1053, 274, 486, 1014, 1015, 503, 1071, 431, 481, 460, 765, 194, 696, 1099, 25, 451, 438, 275, 552, 352, 87, 630, 1047, 941, 345, 349, 429, 854, 1009, 888, 369, 557, 585, 596, 342, 457, 645, 739, 736, 1127, 963, 527, 251, 1115, 1000
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.

More from Philips

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device