Z-1677-2026Class II

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

Name: Z-1677-2026 Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233
Creator: Philips Medical Systems Nederland B.v.
Published: 2026-03-03
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2026-03-03 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233 on 2026-03-03. FDA classified it as Class II and gives the reason as "Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1677-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-03
Posted: 2026-03-27
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Action: On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 6. Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken.
Quantity in commerce: 1994 units (360 US, 1634 OUS)
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, 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;
Product codes and lots: (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, 96, 277, 616, 1140, 211, 850, 223, 1242, 872, 877, 97, 1211, 161, 1132, 386, 1123, 208, 1061, 361, 258, 597, 727, 1008, 1296, 180, 1181, 835, 668, 377, 882, 565, 1103, 196, 130, 1185, 1150, 886, 887, 452, 453, 269, 888, 1188, 567, 966, 449, 435, 441, 669, 351, 508, 750, 164, 139, 355, 619, 1236, 133, 89, 370, 598, 714, 119, 1306, 1307, 871, 697, 698, 1035, 1036, 116, 154, 100, 912, 99, 349, 387, 136, 775, 903, 867, 680, 527, 1227, 629, 1264, 834, 1226, 155, 837, 17, 18, 804, 235, 249, 477, 1025, 1177, 1153, 1210, 167, 1290, 1293, 227, 965, 999, 46, 1131, 141, 1282, 1005, 1129, 1115, 237, 348, 287, 1325, 135, 414, 416, 417, 132, 814, 836, 1245, 356, 809, 810, 303, 1214, 1099, 813, 1167, 1232, 1248, 322, 587, 591, 812, 875, 904, 756, 516, 917, 1016, 10, 1256, 537, 582, 694, 1055, 576, 134, 247, 961, 963, 1222, 1217, 1272, 584, 7, 923, 933, 709, 193, 128, 393, 434, 615, 1165, 854, 550, 657, 1283, 1196, 1258, 407, 1212, 612, 926, 353, 398, 555, 848, 931, 213, 364, 909, 910, 918, 916, 265, 1243, 142, 168, 518, 476, 671, 683, 302, 863, 864, 1033, 894, 25, 1295, 482, 919, 693, 553, 1191, 868, 114, 191, 409, 106, 506, 232, 446, 403, 1125, 823, 670, 803, 1284, 1253, 1254, 579, 289, 703, 705, 311, 776, 1104, 719, 480, 113, 609, 822, 1095, 1137, 1042, 1043, 1078, 519, 521, 520, 522, 523, 524, 525, 526, 858, 362, 375, 747, 272, 81, 661, 723, 821, 862, 140, 761, 63, 109, 1003, 1251, 1041, 1271, 998, 316, 317, 78, 978, 202, 1276, 824, 915, 711, 108, 185, 754, 928, 846, 847, 893, 1262, 1263, 769, 755, 906, 313, 314, 238, 239, 1034, 430, 299, 1247, 363, 40, 574, 486, 354, 710, 279, 280, 281, 845, 960, 306, 992, 989, 618, 225, 226, 173, 212, 8, 9, 157, 165, 344, 1147, 431, 590, 1083, 492, 28, 274, 753, 424, 425, 817, 820, 1237, 818, 819, 1207, 1301, 405, 974, 975, 976, 635, 924, 217, 381, 395, 111, 691, 815, 436, 437, 438, 35, 830, 938, 331, 1010, 1011, 79, 1267, 295, 65, 234, 1246, 796, 337, 1075, 270, 468, 376, 450, 451, 49, 505, 650, 1059, 1259, 1050, 465, 68, 636, 20, 383, 245, 246, 1261, 222, 374, 930, 793, 794, 795, 849, 712, 861, 1291, 325, 907, 908, 859, 605, 61, 544, 1289, 1285, 851, 1201, 921, 589, 1100, 273, 294, 800, 806, 333, 4, 118, 1195, 1197, 1135, 429, 264, 720, 707, 606, 43, 392, 418, 759, 1280, 179, 445, 215, 556, 1027, 21, 442, 791, 807, 76, 922, 1275, 427, 257, 266, 1268, 1336, 228, 460, 554, 194, 954, 956, 174, 1151, 684, 558, 559, 563, 564, 724, 1077, 702, 1092, 48, 779, 422, 583, 573, 413, 995, 541, 600, 183, 6, 1190, 699, 700, 701, 664, 876, 419, 666, 12, 243, 1017, 1037, 283, 1286, 30, 502, 790, 22, 778, 1117, 1239, 540, 169, 485, 26, 787, 507, 396, 382, 176, 986, 685, 682, 1141, 721, 91, 378, 773, 640, 641, 1021, 805, 304, 443, 562, 115, 259, 985, 159, 160, 994, 1186, 170, 82, 199, 271, 988, 481, 828, 860, 278, 219, 461, 549, 802, 66, 298, 552, 285, 497, 962, 534, 1073, 613, 1250, 1270, 1335, 611, 1122, 1124, 692, 766, 996, 997, 652, 900, 614, 517, 1172, 990, 991, 1176, 1310, 957, 780, 781, 1304, 686, 687, 688, 689, 1287, 1288, 1332, 1171, 634, 1198, 979, 1334, 843, 651, 678, 1317, 782, 987, 798, 825, 797, 1302, 1128, 604, 1321, 1322, 935, 838, 1218, 1225, 811, 1328, 762, 758, 1057, 1330, 763, 764, 765, 767, 953, 644, 1169, 1228, 421, 655, 662, 873, 874, 92, 1133, 1136, 632, 792, 218, 784, 760, 535, 542, 543, 895, 426, 1160, 117, 195, 255, 42, 839, 708, 536, 254, 1108, 41, 914, 359, 360, 408, 1019, 642, 90, 643, 286, 288, 290, 72, 74, 80, 1184, 955, 1063, 423, 706, 1252, 291, 483, 1007, 241, 625, 656, 751, 774, 630, 531, 939, 941, 1024, 478, 1143, 645, 646, 647, 648, 786, 660, 2, 840, 24, 674, 358, 1079, 110, 649, 102, 315, 1109, 1235, 38, 673, 1066, 925, 940, 934, 201, 1229, 121, 122, 1189, 902, 1116, 123, 34, 1206, 250, 64, 172, 369, 175, 1298, 1056, 490, 1013, 1014, 1026, 832, 578, 473, 138, 462, 841, 842, 1159, 808, 305, 530, 1074, 474, 475, 515, 620, 768, 857, 913, 103, 27, 603, 1158, 623, 968, 983, 1009, 993, 972, 1199, 1230, 1257, 267, 268, 1209, 293, 639, 1202, 182, 1040, 156, 158, 224, 163, 1157, 389, 1216, 510, 958, 1039, 1081, 444, 1192, 1238, 1045, 83, 491, 420, 1233, 969, 967, 952, 1023, 512, 569, 610, 1030, 551, 1012, 410, 1044, 330, 896, 1178, 251, 406, 404, 1004, 86, 397, 33, 748, 547, 1000, 399, 400, 366, 1018, 513, 345, 380, 94, 621, 95, 13, 428, 672, 1200, 977, 927, 1119, 1120, 1029, 190, 1208, 879, 901, 1224, 296, 297, 263, 342, 539, 726, 494, 1260, 319, 320, 586, 300, 276, 493, 624, 1111, 292, 368, 777, 84, 788, 789, 184, 338, 467, 107, 166, 1193, 898, 622, 1062, 1082, 1053, 200, 509, 532, 653, 1096, 695, 592, 884, 633, 327, 749, 394, 1215, 943, 971; (3) System Code: 722233; UDI: 00884838116764; System Serial Number: 64, 122, 169, 170, 267, 96, 144, 212, 153, 259, 118, 214, 41, 59, 124, 147, 103, 108, 111, 172, 127, 192, 218, 219, 250, 123, 37, 38, 183, 273, 304, 17, 137, 76, 300, 12, 201, 238, 82, 288, 295, 297, 298, 8, 141, 26, 27, 235, 68, 14, 138, 139, 117, 279, 58, 240, 28, 7, 280, 281, 31, 165, 166, 62, 100, 95, 29, 200, 203, 204, 205, 120, 310, 285, 292, 161, 181, 110, 112, 173, 160, 51, 75, 202, 86, 197, 176, 223, 211, 136, 227, 81, 16, 24, 184, 129, 156, 222, 253, 30, 284, 134, 143, 233, 162, 71, 40, 48, 101, 180, 105, 106, 133, 57, 61, 186, 189, 89, 90, 91, 145, 44, 231, 268, 312, 85, 221, 193, 194, 83, 84, 87, 88, 19, 5, 6, 18, 178, 60, 257, 55, 239, 243, 130, 234, 9, 32, 159, 217, 260, 56, 20, 225, 291, 50, 11, 72, 107, 35, 46, 47, 74, 43, 104, 78, 290, 272, 249, 77, 80, 174, 163, 97, 102, 146, 148, 149, 109, 15, 13, 39, 206, 67;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1677-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1659-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1660-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1661-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1662-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1663-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1664-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1665-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1666-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1667-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1668-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1669-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1670-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1671-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1672-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1673-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1674-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1675-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1676-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1677-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1678-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1679-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27
Z-1680-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-03-27

Product code OWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)