Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197, 162, 517, 218, 797, 444, 489, 222, 361, 362, 977, 30, 579, 223, 584, 618, 909, 193, 280, 962, 893, 287, 263, 174, 156, 27, 194, 953, 356, 182, 958, 847, 959, 713, 610, 325, 284, 527, 189, 614, 600, 864, 760, 490, 103, 140, 184, 506, 342, 673, 674, 675, 676, 23, 112, 750, 199, 363, 217, 151, 152, 160, 815, 695, 135, 985, 1058, 1077, 1047, 940, 942, 945, 946, 947, 948, 1008, 1032, 749, 918, 919, 989, 984, 1011, 701, 907, 1015, 735, 736, 856, 898, 1037, 1051, 1086, 1000, 987, 819, 820, 1057, 1081, 798, 992, 1036, 993, 986, 710, 1069, 1070, 1071, 1072, 971, 849, 1004, 1068, 1043, 1059, 1034, 1046, 1064, 1065, 1066, 1067, 1009, 716, 717, 994, 1075, 1074, 1084, 1085, 1073, 1079, 1062, 1063, 926, 687, 688, 1056, 1045, 1048, 1049, 1033, 1035, 899, 1061, 970, 875, 1026, 964, 965, 1039, 1080, 1052, 407, 408, 505, 581, 850, 643, 314, 316, 976, 806, 502, 200, 943, 957, 1013, 1025, 354, 991, 551, 775, 776, 320, 295, 547, 123, 319, 525, 318, 586, 879, 127, 128, 130, 132, 133, 686, 805, 346, 347, 398, 24, 564, 604, 690, 769, 570, 572, 565, 470, 562, 378, 414, 727, 38, 703, 865, 621, 348, 881, 453, 468, 142, 374, 375, 126, 726, 751, 469, 114, 689, 845, 430, 149, 499, 625, 897, 261, 472, 254, 255, 267, 268, 368, 369, 243, 244, 731, 202, 282, 283, 351, 442, 636, 40, 172, 642, 477, 134, 262, 341, 563, 486, 633, 21, 705, 286, 336, 512, 158, 357, 233, 397, 896, 281, 52, 190, 366, 617, 496, 461, 463, 777, 129, 270, 528, 529, 638, 431, 712, 714, 219, 203, 575, 345, 934, 498, 574, 577, 853, 668, 779, 548, 37, 620, 1031, 306, 377, 381, 988, 782, 237, 540, 601, 424, 596, 597, 662, 440, 628, 952, 422, 259, 935, 510, 33, 954, 196, 371, 10, 148, 476, 507, 762, 503, 950, 854, 846, 213, 227, 561, 663, 380, 778, 462, 464, 891, 542, 968, 680, 315, 831, 841, 905, 830, 843, 842, 682, 501, 323, 683, 567, 884, 602, 153, 154, 173, 418, 761, 139, 178, 179, 264, 265, 266, 511, 526, 746, 201, 353, 487, 495, 186, 122, 338, 518, 303, 304, 509, 515, 432, 433, 310, 18, 582, 19, 416, 530, 664, 11, 155, 435, 715, 685, 508, 543, 516, 16, 908, 167, 446, 12, 225, 913, 901, 198, 504, 961, 457, 967, 647, 367, 980, 981, 982, 328, 343, 344, 764, 770, 771, 772, 773, 972, 800, 648, 191, 652, 917, 578, 912, 169, 426, 650, 471, 419, 236, 979, 938, 667, 619, 541, 738, 324, 365, 1003, 835, 836, 929, 975, 252, 36, 242, 622, 623, 629, 207, 208, 209, 210, 211, 300, 301, 795, 32, 241, 785, 49, 50, 51, 145, 250, 774, 474, 475, 452, 624, 447, 839, 333, 837, 404, 681, 26, 692, 183, 651, 177, 615, 423, 554, 181, 816, 616, 696, 672, 175, 855, 434, 358, 722, 439, 789, 552, 1010, 871, 874, 1029, 1030, 869, 939, 180, 990, 28, 29, 659, 339, 340, 20, 458, 421, 138, 157, 752, 355, 307, 553, 593, 944, 857, 382, 428, 599, 467, 630, 729, 102, 370, 450, 147, 429, 449, 757, 216, 743, 759, 334, 451, 960, 159, 400, 401, 411, 124, 13, 14, 15, 818, 459, 460, 352, 46, 39, 311, 312, 277, 718, 698, 150, 693, 694, 589, 784, 482, 235, 792, 590, 485, 796, 838, 349, 1005, 226, 920, 272, 877, 322, 978, 455, 641, 631, 632, 220, 221, 146, 609, 448, 466, 704, 801, 802, 492, 533, 41, 42, 43, 44, 45, 669, 35, 321, 332, 331, 817, 699, 144, 594, 192, 799, 608, 878, 732, 768, 637, 670, 335, 253, 549, 892; (2) 580, 669, 282, 357, 367, 164, 799, 124, 1060, 1107, 36, 570, 665, 455, 457, 301, 456, 704, 131, 441, 277, 616, 750, 872, 877, 816, 1144, 365, 390, 1015, 69, 1103, 599, 601, 602, 470, 171, 432, 352, 1084, 340, 892, 597, 97, 242, 361, 161, 205, 627, 514, 628, 198, 371, 229, 230, 262, 261, 328, 727, 560, 561, 463, 487, 1113, 214, 318, 458, 883, 889, 508, 566, 256, 351, 596, 1140, 637, 638, 433, 728, 937, 944, 945, 951, 533, 323, 180, 659, 377, 435, 439, 1051, 1008, 452, 453, 681, 77, 127, 1179, 47, 67, 932, 252, 626, 126, 905, 386, 565, 308, 449, 886, 887, 1150, 577, 85, 312, 324, 332, 585, 96, 44, 343, 1231, 221, 880, 746, 966, 105, 572, 852, 801, 269, 192, 197, 87, 204, 1181, 1114, 1161, 188, 130, 52, 379, 440, 668, 888, 177, 223, 503, 196, 882, 208, 1123, 104, 334, 388, 581, 855, 207, 189, 479, 329, 448, 495, 571, 211, 186, 187, 631, 567, 1001, 1097, 829, 206, 210, 336, 373, 258, 679, 1088, 125, 1065, 391, 454, 37, 119, 136, 370, 116, 154, 349, 387, 89, 133, 99, 100, 912, 697, 698, 139, 355, 871, 1236, 1035, 1036, 775, 903, 598, 867, 619, 445, 222, 854, 1191, 756, 436, 437, 438, 325, 999, 879, 787, 1033, 530, 579, 553, 278, 779, 78, 1129, 381, 926, 706, 1165, 202, 38, 859, 430, 940, 313, 314, 201, 185, 1083, 857, 860, 382, 1109, 846, 847, 169, 102, 649, 645, 646, 647, 648, 1143, 108, 786, 578, 650, 1128, 986, 1057, 990, 991, 987, 1055, 1169, 780, 781, 825, 1245, 758, 1171, 652, 900, 651, 604, 843, 782, 1124, 1172, 957, 1176, 901, 763, 764, 765, 767, 1013, 1014, 996, 997, 838, 1026, 798, 823, 979, 686, 687, 688, 689, 1275, 692, 953, 611, 644, 1218, 1016, 1115, 797, 917, 1225, 762, 1214, 517, 1198, 634, 678, 924, 443, 132, 296, 297, 41, 914, 461, 30, 808, 298, 552, 165, 24, 117, 195, 1160, 793, 794, 795, 173, 212, 267, 268, 306, 243, 655, 656, 662, 664, 537, 694, 419, 666, 413, 271, 468, 270, 255, 573, 1100, 558, 559, 563, 564, 33, 541, 224, 606, 965, 354, 711, 356, 934, 414, 416, 417, 671, 403, 933, 804, 710, 287, 114, 311, 863, 864, 915, 925, 237, 26, 919, 238, 239, 574, 289, 286, 288, 290, 1066, 247, 961, 963, 906, 824, 249, 477, 814, 155, 837, 486, 141, 809, 810, 353, 398, 555, 279, 280, 281, 909, 910, 25, 693, 506, 1034, 17, 18, 10, 1125, 476, 142, 168, 235, 227, 661, 176, 708, 321, 431, 43, 123, 913, 245, 246, 673, 422, 61, 380, 2, 639, 91, 333, 1056, 761, 21, 95, 531, 1017, 1037, 992, 392, 358, 283, 618, 590, 65, 295, 985, 64, 840, 12, 218, 68, 465, 547, 702, 1077, 800, 806, 376, 450, 451, 876, 792, 34, 672, 1197, 140, 63, 818, 819, 988, 8, 9, 49, 442, 20, 383, 1078, 790, 1003, 157, 539, 726, 342, 232, 492, 1199, 902, 562, 834, 632, 1059, 128, 483, 549, 998, 802, 369, 527, 811, 106, 1226, 670, 76, 135, 1133, 1136, 550, 175, 304, 219, 303, 516, 172, 803, 895, 482, 861, 1235, 46, 213, 724, 316, 317, 250, 254, 1210, 66, 113, 691, 1153, 748, 111, 462, 1108, 1159, 962, 1196, 363, 609, 629, 299, 832, 796, 134, 423, 1189, 426, 291, 636, 167, 747, 576, 851, 534, 974, 975, 976, 657, 1151, 174, 228, 954, 194, 956, 257, 460, 554, 519, 520, 521, 522, 523, 524, 525, 526, 858, 960, 845, 977, 1200, 760, 1010, 1075, 234, 322, 587, 591, 812, 875, 904, 1167, 1232, 444, 1081, 551, 1184, 478, 1024, 1018, 330, 1044, 1000, 420, 1019, 405, 1004, 251, 404, 408, 1192, 1023, 1238, 967, 491, 410, 90, 642, 513, 1178, 1012, 406, 396, 366, 1039, 345, 969, 399, 400, 359, 360, 955, 395, 397, 896, 1030, 512, 86, 569, 610, 972, 507, 509, 338, 1111, 943, 971, 107, 368, 788, 789, 1062, 292, 394, 884, 327, 166, 467, 622, 695, 898, 200, 1082, 532, 184, 1053, 777, 633, 84, 749, 592, 1193, 1215, 653, 190, 1029, 1237, 643, 446, 293, 848, 589, 480, 1207, 199, 922, 849, 490, 719, 921, 703, 705, 1025, 709, 215, 556, 723, 821, 862, 82, 364, 813, 1099, 612, 680, 683, 1092, 1073, 684, 614, 682, 518, 685, 613, 1141, 918, 923, 505, 1228, 1177, 485, 266, 393, 434, 615, 109, 170, 4, 640, 641, 542, 543, 1021, 121, 122, 699, 700, 701, 805, 938, 374, 1195, 118, 13, 428, 429, 939, 941, 1042, 1043, 630, 331, 389, 930, 81, 272, 1041, 159, 160, 1206, 1095, 927, 510, 958, 27, 603, 1190, 1137, 263, 309, 110, 315, 893, 983, 1009, 712, 660, 305, 179, 968, 623, 515, 494, 300, 493, 586, 624, 276, 319, 320, 407, 894, 48, 241, 625, 1007, 1122, 868, 72, 74, 80, 94, 928, 274, 769, 42, 754, 674, 264, 720, 28, 721, 753, 755, 424, 425, 817, 820, 839, 583, 302, 427, 1117, 873, 874, 22, 778, 1050, 1157, 605, 344, 841, 842, 540, 620, 768, 1027, 1147, 474, 475, 1074, 989, 916, 1005, 409, 137, 836, 931, 1104, 265, 7, 584, 1217, 776, 791, 807, 1212, 348, 600, 138, 473, 421, 103, 285, 497, 163, 182, 191, 830, 183, 79, 751, 774, 83, 1045, 362, 375, 815, 115, 259, 907, 908, 156, 158, 1040, 1135, 217, 707, 35, 822, 40, 273, 337, 544, 92, 502, 621, 225, 226, 995, 994, 1119, 1120, 635, 294, 378, 773, 536, 535 ****Serial Numbers Added 5/2/2025**** ; 1038, 1052, 1061, 1067, 1106, 1130, 1132, 1185, 1188, 1211, 1241, 1242; (3) OUS ONLY 6, 7, 8, 9, 24 ****Serial Numbers Added 5/2/2025**** 5, 11, 12, 15, 16, 17, 18, 19, 20, 48, 27, 28, 29, 31, 32, 35, 37, 38, 39, 40, 43, 44, 46, 47, 48, 50, 51, 55, 57, 58, 60, 61, 62, 71, 74, 77, 80, 81, 85, 86, 87, 89, 90, 91, 97, 102, 104, 134.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Reason for Recall:
Possibility of the patient falling from the table related to the mattress used on the patient table.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

Product Codes/Lot Numbers:

Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY); UDI-DI: (1) 00884838085251, (2) 00884838099241, (3) 00884838116764; Serial Numbers: (1) 465, 437, 438, 143, 302, 559, 170, 824, 626, 697, 278, 491, 215, 720, 612, 788, 141, 644, 279, 402, 290, 524, 415, 890, 412, 166, 136, 539, 532, 538, 291, 483, 497, 576, 500, 379, 753, 677, 709, 649, 441, 305, 289, 22, 257, 258, 187, 803, 399, 613, 121, 396, 536, 537, 488, 566, 833, 456, 478, 479, 224, 309, 719, 163, 921, 296, 364, 684, 239, 383, 249, 125, 829, 513, 376, 627, 725, 728, 611, 308, 522, 862, 1007, 661, 298, 571, 654, 656, 657, 658, 292, 844, 876, 480, 481, 410, 271, 493, 327, 550, 723, 269, 185, 902, 445, 360, 232, 425, 635, 546, 748, 294, 906, 603, 645, 870, 544, 545, 523, 520, 521, 556, 557, 558, 293, 840, 598, 384, 317, 535, 359, 700, 251, 786, 240, 256, 436, 585, 31, 165, 247, 733, 204, 205, 206, 888, 923, 195, 197, 162, 517, 218, 797, 444, 489, 222, 361, 362, 977, 30, 579, 223, 584, 618, 909, 193, 280, 962, 893, 287, 263, 174, 156, 27, 194, 953, 356, 182, 958, 847, 959, 713, 610, 325, 284, 527, 189, 614, 600, 864, 760, 490, 103, 140, 184, 506, 342, 673, 674, 675, 676, 23, 112, 750, 199, 363, 217, 151, 152, 160, 815, 695, 135, 985, 1058, 1077, 1047, 940, 942, 945, 946, 947, 948, 1008, 1032, 749, 918, 919, 989, 984, 1011, 701, 907, 1015, 735, 736, 856, 898, 1037, 1051, 1086, 1000, 987, 819, 820, 1057, 1081, 798, 992, 1036, 993, 986, 710, 1069, 1070, 1071, 1072, 971, 849, 1004, 1068, 1043, 1059, 1034, 1046, 1064, 1065, 1066, 1067, 1009, 716, 717, 994, 1075, 1074, 1084, 1085, 1073, 1079, 1062, 1063, 926, 687, 688, 1056, 1045, 1048, 1049, 1033, 1035, 899, 1061, 970, 875, 1026, 964, 965, 1039, 1080, 1052, 407, 408, 505, 581, 850, 643, 314, 316, 976, 806, 502, 200, 943, 957, 1013, 1025, 354, 991, 551, 775, 776, 320, 295, 547, 123, 319, 525, 318, 586, 879, 127, 128, 130, 132, 133, 686, 805, 346, 347, 398, 24, 564, 604, 690, 769, 570, 572, 565, 470, 562, 378, 414, 727, 38, 703, 865, 621, 348, 881, 453, 468, 142, 374, 375, 126, 726, 751, 469, 114, 689, 845, 430, 149, 499, 625, 897, 261, 472, 254, 255, 267, 268, 368, 369, 243, 244, 731, 202, 282, 283, 351, 442, 636, 40, 172, 642, 477, 134, 262, 341, 563, 486, 633, 21, 705, 286, 336, 512, 158, 357, 233, 397, 896, 281, 52, 190, 366, 617, 496, 461, 463, 777, 129, 270, 528, 529, 638, 431, 712, 714, 219, 203, 575, 345, 934, 498, 574, 577, 853, 668, 779, 548, 37, 620, 1031, 306, 377, 381, 988, 782, 237, 540, 601, 424, 596, 597, 662, 440, 628, 952, 422, 259, 935, 510, 33, 954, 196, 371, 10, 148, 476, 507, 762, 503, 950, 854, 846, 213, 227, 561, 663, 380, 778, 462, 464, 891, 542, 968, 680, 315, 831, 841, 905, 830, 843, 842, 682, 501, 323, 683, 567, 884, 602, 153, 154, 173, 418, 761, 139, 178, 179, 264, 265, 266, 511, 526, 746, 201, 353, 487, 495, 186, 122, 338, 518, 303, 304, 509, 515, 432, 433, 310, 18, 582, 19, 416, 530, 664, 11, 155, 435, 715, 685, 508, 543, 516, 16, 908, 167, 446, 12, 225, 913, 901, 198, 504, 961, 457, 967, 647, 367, 980, 981, 982, 328, 343, 344, 764, 770, 771, 772, 773, 972, 800, 648, 191, 652, 917, 578, 912, 169, 426, 650, 471, 419, 236, 979, 938, 667, 619, 541, 738, 324, 365, 1003, 835, 836, 929, 975, 252, 36, 242, 622, 623, 629, 207, 208, 209, 210, 211, 300, 301, 795, 32, 241, 785, 49, 50, 51, 145, 250, 774, 474, 475, 452, 624, 447, 839, 333, 837, 404, 681, 26, 692, 183, 651, 177, 615, 423, 554, 181, 816, 616, 696, 672, 175, 855, 434, 358, 722, 439, 789, 552, 1010, 871, 874, 1029, 1030, 869, 939, 180, 990, 28, 29, 659, 339, 340, 20, 458, 421, 138, 157, 752, 355, 307, 553, 593, 944, 857, 382, 428, 599, 467, 630, 729, 102, 370, 450, 147, 429, 449, 757, 216, 743, 759, 334, 451, 960, 159, 400, 401, 411, 124, 13, 14, 15, 818, 459, 460, 352, 46, 39, 311, 312, 277, 718, 698, 150, 693, 694, 589, 784, 482, 235, 792, 590, 485, 796, 838, 349, 1005, 226, 920, 272, 877, 322, 978, 455, 641, 631, 632, 220, 221, 146, 609, 448, 466, 704, 801, 802, 492, 533, 41, 42, 43, 44, 45, 669, 35, 321, 332, 331, 817, 699, 144, 594, 192, 799, 608, 878, 732, 768, 637, 670, 335, 253, 549, 892; (2) 580, 669, 282, 357, 367, 164, 799, 124, 1060, 1107, 36, 570, 665, 455, 457, 301, 456, 704, 131, 441, 277, 616, 750, 872, 877, 816, 1144, 365, 390, 1015, 69, 1103, 599, 601, 602, 470, 171, 432, 352, 1084, 340, 892, 597, 97, 242, 361, 161, 205, 627, 514, 628, 198, 371, 229, 230, 262, 261, 328, 727, 560, 561, 463, 487, 1113, 214, 318, 458, 883, 889, 508, 566, 256, 351, 596, 1140, 637, 638, 433, 728, 937, 944, 945, 951, 533, 323, 180, 659, 377, 435, 439, 1051, 1008, 452, 453, 681, 77, 127, 1179, 47, 67, 932, 252, 626, 126, 905, 386, 565, 308, 449, 886, 887, 1150, 577, 85, 312, 324, 332, 585, 96, 44, 343, 1231, 221, 880, 746, 966, 105, 572, 852, 801, 269, 192, 197, 87, 204, 1181, 1114, 1161, 188, 130, 52, 379, 440, 668, 888, 177, 223, 503, 196, 882, 208, 1123, 104, 334, 388, 581, 855, 207, 189, 479, 329, 448, 495, 571, 211, 186, 187, 631, 567, 1001, 1097, 829, 206, 210, 336, 373, 258, 679, 1088, 125, 1065, 391, 454, 37, 119, 136, 370, 116, 154, 349, 387, 89, 133, 99, 100, 912, 697, 698, 139, 355, 871, 1236, 1035, 1036, 775, 903, 598, 867, 619, 445, 222, 854, 1191, 756, 436, 437, 438, 325, 999, 879, 787, 1033, 530, 579, 553, 278, 779, 78, 1129, 381, 926, 706, 1165, 202, 38, 859, 430, 940, 313, 314, 201, 185, 1083, 857, 860, 382, 1109, 846, 847, 169, 102, 649, 645, 646, 647, 648, 1143, 108, 786, 578, 650, 1128, 986, 1057, 990, 991, 987, 1055, 1169, 780, 781, 825, 1245, 758, 1171, 652, 900, 651, 604, 843, 782, 1124, 1172, 957, 1176, 901, 763, 764, 765, 767, 1013, 1014, 996, 997, 838, 1026, 798, 823, 979, 686, 687, 688, 689, 1275, 692, 953, 611, 644, 1218, 1016, 1115, 797, 917, 1225, 762, 1214, 517, 1198, 634, 678, 924, 443, 132, 296, 297, 41, 914, 461, 30, 808, 298, 552, 165, 24, 117, 195, 1160, 793, 794, 795, 173, 212, 267, 268, 306, 243, 655, 656, 662, 664, 537, 694, 419, 666, 413, 271, 468, 270, 255, 573, 1100, 558, 559, 563, 564, 33, 541, 224, 606, 965, 354, 711, 356, 934, 414, 416, 417, 671, 403, 933, 804, 710, 287, 114, 311, 863, 864, 915, 925, 237, 26, 919, 238, 239, 574, 289, 286, 288, 290, 1066, 247, 961, 963, 906, 824, 249, 477, 814, 155, 837, 486, 141, 809, 810, 353, 398, 555, 279, 280, 281, 909, 910, 25, 693, 506, 1034, 17, 18, 10, 1125, 476, 142, 168, 235, 227, 661, 176, 708, 321, 431, 43, 123, 913, 245, 246, 673, 422, 61, 380, 2, 639, 91, 333, 1056, 761, 21, 95, 531, 1017, 1037, 992, 392, 358, 283, 618, 590, 65, 295, 985, 64, 840, 12, 218, 68, 465, 547, 702, 1077, 800, 806, 376, 450, 451, 876, 792, 34, 672, 1197, 140, 63, 818, 819, 988, 8, 9, 49, 442, 20, 383, 1078, 790, 1003, 157, 539, 726, 342, 232, 492, 1199, 902, 562, 834, 632, 1059, 128, 483, 549, 998, 802, 369, 527, 811, 106, 1226, 670, 76, 135, 1133, 1136, 550, 175, 304, 219, 303, 516, 172, 803, 895, 482, 861, 1235, 46, 213, 724, 316, 317, 250, 254, 1210, 66, 113, 691, 1153, 748, 111, 462, 1108, 1159, 962, 1196, 363, 609, 629, 299, 832, 796, 134, 423, 1189, 426, 291, 636, 167, 747, 576, 851, 534, 974, 975, 976, 657, 1151, 174, 228, 954, 194, 956, 257, 460, 554, 519, 520, 521, 522, 523, 524, 525, 526, 858, 960, 845, 977, 1200, 760, 1010, 1075, 234, 322, 587, 591, 812, 875, 904, 1167, 1232, 444, 1081, 551, 1184, 478, 1024, 1018, 330, 1044, 1000, 420, 1019, 405, 1004, 251, 404, 408, 1192, 1023, 1238, 967, 491, 410, 90, 642, 513, 1178, 1012, 406, 396, 366, 1039, 345, 969, 399, 400, 359, 360, 955, 395, 397, 896, 1030, 512, 86, 569, 610, 972, 507, 509, 338, 1111, 943, 971, 107, 368, 788, 789, 1062, 292, 394, 884, 327, 166, 467, 622, 695, 898, 200, 1082, 532, 184, 1053, 777, 633, 84, 749, 592, 1193, 1215, 653, 190, 1029, 1237, 643, 446, 293, 848, 589, 480, 1207, 199, 922, 849, 490, 719, 921, 703, 705, 1025, 709, 215, 556, 723, 821, 862, 82, 364, 813, 1099, 612, 680, 683, 1092, 1073, 684, 614, 682, 518, 685, 613, 1141, 918, 923, 505, 1228, 1177, 485, 266, 393, 434, 615, 109, 170, 4, 640, 641, 542, 543, 1021, 121, 122, 699, 700, 701, 805, 938, 374, 1195, 118, 13, 428, 429, 939, 941, 1042, 1043, 630, 331, 389, 930, 81, 272, 1041, 159, 160, 1206, 1095, 927, 510, 958, 27, 603, 1190, 1137, 263, 309, 110, 315, 893, 983, 1009, 712, 660, 305, 179, 968, 623, 515, 494, 300, 493, 586, 624, 276, 319, 320, 407, 894, 48, 241, 625, 1007, 1122, 868, 72, 74, 80, 94, 928, 274, 769, 42, 754, 674, 264, 720, 28, 721, 753, 755, 424, 425, 817, 820, 839, 583, 302, 427, 1117, 873, 874, 22, 778, 1050, 1157, 605, 344, 841, 842, 540, 620, 768, 1027, 1147, 474, 475, 1074, 989, 916, 1005, 409, 137, 836, 931, 1104, 265, 7, 584, 1217, 776, 791, 807, 1212, 348, 600, 138, 473, 421, 103, 285, 497, 163, 182, 191, 830, 183, 79, 751, 774, 83, 1045, 362, 375, 815, 115, 259, 907, 908, 156, 158, 1040, 1135, 217, 707, 35, 822, 40, 273, 337, 544, 92, 502, 621, 225, 226, 995, 994, 1119, 1120, 635, 294, 378, 773, 536, 535 ****Serial Numbers Added 5/2/2025**** ; 1038, 1052, 1061, 1067, 1106, 1130, 1132, 1185, 1188, 1211, 1241, 1242; (3) OUS ONLY 6, 7, 8, 9, 24 ****Serial Numbers Added 5/2/2025**** 5, 11, 12, 15, 16, 17, 18, 19, 20, 48, 27, 28, 29, 31, 32, 35, 37, 38, 39, 40, 43, 44, 46, 47, 48, 50, 51, 55, 57, 58, 60, 61, 62, 71, 74, 77, 80, 81, 85, 86, 87, 89, 90, 91, 97, 102, 104, 134.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1159-2025

Related Recalls

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.

Oct 2, 2025 Other Medical Devices Nationwide View Details →

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Sep 3, 2025 Other Medical Devices Nationwide View Details →