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Moderate riskFDA DeviceClass II

Philips Azurion 7 M20 X-ray system recalled for intermittent foot switch failure

Philips Medical Systems has identified a problem with the wired foot switch on certain Azurion 7 M20 X-ray imaging systems. The foot switch may fail to initiate X-ray imaging or cause imaging to occur intermittently, which could affect patient care and diagnostic imaging procedures.

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

What to do

  1. Contact Philips Medical Systems immediately if you operate an affected Azurion 7 M20 system
  2. Stop using the wired foot switch until you receive instructions from Philips
  3. Check your system serial number against the FDA recall list
  4. Follow Philips' guidance for repair or replacement of the foot switch
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
5167 units (1728 US, 3439 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1678-2026

In the FDA's words

Description
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); 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: 722079; UDI: 00884838085268; System Serial Number: 1023, 645, 646, 1013, 1387, 460, 35, 40, 43, 703307, 703904, 1048, 1137, 401, 1010, 1054, 266, 534, 535, 536, 818, 412, 617, 246, 488, 53, 57, 905, 55, 691, 992, 809, 848, 1033, 836, 891, 1155, 466, 1157, 1395, 703559, 263, 420, 703391, 673, 297, 298, 299, 564, 838, 1032, 1117, 987, 1310, 1211, 1213, 47, 1365, 1408, 881, 774, 856, 922, 58, 471, 1012, 755, 633, 703540, 296, 703558, 574, 703336, 842, 884, 991, 753, 703493, 1086, 790, 840, 407, 408, 481, 703350, 877, 703395, 703323, 703775, 590, 709, 710, 711, 713, 716, 1216, 483, 1098, 1392, 241, 703408, 1108, 1363, 1355, 1414, 703387, 703404, 863, 350, 528, 703465, 1380, 908, 1238, 1378, 262, 598, 858, 859, 275, 703861, 520, 335, 1018, 593, 911, 480, 1410, 703329, 213, 325, 496, 887, 903, 703413, 1432, 594, 1309, 1312, 999, 1424, 465, 674, 1084, 353, 499, 1230, 813, 703508, 33, 1346, 1189, 1401, 361, 267, 403, 439, 526, 1021, 736, 1370, 608, 68, 703324, 611, 413, 414, 415, 453, 703306, 895, 703615, 587, 1297, 1399, 428, 883, 1267, 422, 758, 1040, 634, 573, 714, 274, 525, 843, 885, 1276, 1102, 703478, 1142, 792, 919, 703528, 754, 599, 1171, 1096, 1097, 766, 817, 78, 703419, 1322, 878, 1170, 1107, 703435, 703310, 944, 654, 703521, 273, 703305, 715, 703495, 1285, 854, 19, 904, 1005, 804, 703497, 730, 1400, 954, 375, 957, 697, 703332, 658, 423, 1022, 896, 897, 1411, 1430, 621, 703426, 628, 795, 272, 1007, 940, 250, 46, 1289, 605, 65, 360, 468, 472, 469, 828, 737, 925, 32, 857, 703416, 703327, 34, 1222, 1268, 1063, 703335, 769, 938, 655, 229, 738, 1204, 1311, 572, 776, 538, 797, 989, 946, 888, 393, 394, 1062, 52, 703396, 703420, 281, 939, 703407, 1219, 955, 402, 1042, 867, 868, 909, 931, 703425, 374, 459, 1282, 841, 703532, 1436, 703344, 1358, 1359, 1360, 1391, 703389, 50, 1006, 1352, 580, 581, 703309, 703383, 703510, 974, 1245, 396, 860, 326, 741, 584, 721, 216, 899, 703, 927, 928, 923, 981, 865, 1163, 416, 268, 689, 717, 497, 900, 1369, 424, 1258, 1323, 959, 447, 448, 1385, 1386, 852, 1252, 802, 915, 703379, 703402, 751, 704281, 436, 703311, 1402, 910, 866, 703418, 1242, 354, 708, 251, 703501, 1064, 1156, 1049, 342, 343, 344, 345, 1271, 631, 18, 479, 1103, 1361, 577, 1041, 1423, 29, 1043, 1270, 1250, 805, 930, 1200, 228, 30, 366, 543, 588, 355, 356, 357, 358, 359, 1090, 445, 703314, 945, 1226, 1232, 1236, 1237, 853, 801, 1187, 222, 247, 474, 62, 70, 703450, 537, 48, 351, 777, 41, 898, 703317, 653, 684, 703334, 912, 746, 703368, 703562, 54, 1231, 731, 540, 998, 618, 1179, 703360, 1283, 668, 1431, 607, 706, 847, 879, 703308, 837, 1251, 703575, 387, 417, 1316, 45, 1393, 1290, 334, 320, 429, 212, 290, 703409, 239, 669, 703390, 629, 1078, 800, 56, 703584, 470, 595, 64, 671, 793, 1059, 1381, 1382, 747, 585, 1246, 663, 1212, 703333, 1274, 255, 455, 637, 862, 1379, 1235, 810, 1164, 227, 437, 438, 703345, 990, 314, 613, 427, 60, 1100, 703486, 602, 318, 937, 703515, 703455, 703456, 703457, 942, 948, 1201, 1247, 702, 333, 703388, 644, 845, 846, 1415, 1000, 814, 284, 352, 703356, 703380, 703381, 265, 679, 328, 329, 330, 331, 332, 1017, 1039, 1374, 750, 1016, 783, 703550, 703685, 703551, 703813, 704301, 780, 703719, 217, 476, 815, 816, 214, 703565, 1280, 704304, 561, 59, 703338, 719, 894, 744, 745, 704059, 729, 943, 302, 31, 337, 703552, 703613, 704240, 704242, 703662, 1340, 549, 703838, 1037, 703823, 703670, 1026, 377, 379, 380, 1405, 258, 259, 260, 395, 433, 451, 662, 703355, 703449, 703654, 703699, 703870, 703612, 704299, 704300, 703899, 1306, 970, 1248, 822, 449, 1047, 1019, 1241, 557, 1143, 752, 704129, 558, 947, 1190, 1196, 1172, 1319, 703712, 1397, 1398, 289, 704295, 994, 703326, 703655, 703702, 703939, 531, 703802, 703897, 704203, 704266, 1389, 703953, 703986, 703600, 570, 703769, 458, 962, 703374, 703710, 704026, 703592, 215, 703384, 703392, 545, 703753, 703967, 704112, 984, 703992, 703807, 1036, 1351, 703463, 703818, 871, 703529, 1073, 704154, 778, 548, 798, 704037, 933, 316, 703669, 704290, 234, 1429, 313, 49, 704209, 722, 703619, 704142, 378, 418, 1053, 600, 825, 452, 969, 1020, 1265, 763, 703545, 703358, 1095, 703487, 704092, 461, 1239, 703867, 786, 578, 703572, 559, 560, 982, 703462, 464, 703583, 1106, 1044, 703855, 704127, 1205, 1206, 1214, 450, 703348, 252, 703872, 430, 997, 271, 312, 1338, 855, 1169, 1030, 1120, 339, 1121, 934, 1168, 1150, 699, 704199, 703489, 703959, 913, 563, 304, 1191, 567, 566, 916, 388, 707, 1195, 1193, 301, 554, 555, 704282, 704284, 1083, 703966, 303, 305, 704101, 1194, 785, 703961, 1337, 993, 688, 347, 772, 74, 632, 383, 735, 39, 1074, 230, 1182, 1341, 293, 936, 703944, 704258, 295, 675, 949, 411, 701, 287, 286, 232, 760, 421, 726, 1109, 1144, 434, 591, 61, 961, 1072, 1185, 703477, 257, 661, 704146, 703982, 1440, 1441, 1442, 389, 703438, 703783, 7042
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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