PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

Hazard

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

Details from the source

Reason for recall: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Quantity: 5167 units (1728 US, 3439 OUS) Lot/code info: (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,

UPC codes

00884838085268, 00884838099258, 00884838116771, 00884838110571

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.