FDA-Device2026-04-08Class II

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Hazard

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

Sold states

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, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;

Affected count

1994 units (360 US, 1634 OUS)

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1677-2026

Original summary

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,

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