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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96132

20 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 13, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

20 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 20

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

Z-1142-2025
Recall number
Z-1142-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
2,274 units (459 US, 1815 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) No UDI, (2) 00884838059030, (3) 00884838054189; Serial Numbers: (1) 285, 1634, 1349, 1153, 1154, 1472, 803, 1694, 1599, 1460, 1138, 1532, 940, 1214, 1627, 1728, 1189, 1311, 1700, 1187, 1222, 1651, 1353, 939, 1326, 445, 1223, 76986, 1023, 917, 1615, 1732, 1761, 367, 1078, 690, 1529, 1624, 997616, 1663, 1667, 928, 1449, 968, 1286, 72, 1621, 1622, 1643, 472, 1799, 1514, 1525, 1114, 1584, 1647, 1555, 1482, 1489, 1443, 1444, 1072, 1954, 1704, 1232, 1266, 1089, 1259, 1787, 1910, 1714, 1159, 1133, 1135, 1512, 892, 1084, 1031, 1067, 2936, 1411, 1271, 1807, 871, 1805, 1354, 1430, 8198, 1869, 634919, 485, 1594, 467, 1551, 390, 912, 913, 8091, 1471, 1474, 1446, 1092, 1718, 833, 1491, 1738, 1749, 1637, 1255, 1462, 1132, 1463, 1633, 1374, 1675, 691, 292, 1751, 1802, 1593, 1105, 1107, 1108, 1702, 1277, 1684, 1568, 1569, 1570, 1743, 1109, 1620, 1726, 639, 797, 1377, 1065, 4.5161E+15, 1708, 1709, 1328, 1592, 1121, 1295, 1104, 1064, 1063, 949, 1173, 1396, 1582, 1537, 1664, 1193, 1717, 1445, 1576, 1511, 1119, 1735, 1548, 1566, 1680, 1632, 1113, 1752, 875, 281, 1059, 1273, 1578, 1558, 354, 469, 1544, 1746, 1747, 1212, 5, 535, 1931, 416, 1496, 369, 1176, 1169, 249, 492, 1016, 1774, 1697, 807, 1885, 499, 93, 1930, 1246, 1916, 82, 1325, 1230, 1524, 1457, 728, 747, 1860, 676, 329, 1928, 1925, 1661, 708, 1598, 605, 679, 1025, 861, 1908, 614, 1399, 356, 424, 1495, 1, 1118, 1927, 328, 1919, 1149, 782, 1414, 1101, CV.615, 313, 314, 1923, 1653, 1398, 789, 790, 205, 272348, 2674, 1352, 899, 1666, 883, 162, 1723, 1447, 1458, 1585, 1755, 1756, 517, 339, 3298, 1730, 990, 1130, 1818, 1638, 1712, 1646, 1784, 1022, 1631, 1630, 1492, 1056, 1538, 1586, 1483, 1231, 1897, 1834, 1619, 1407, 1293, 1207, 1409, 1412, 1500, 1501, 1572, 319, 1338, 1395, 452, 1038, 1045, 1536, 1527, 1172, 1090, 1077, 1857, 1823, 1764, 346, 1027, 1595, 961, 1112, 1469, 1478, 1692, 1509, 1203, 1567, 1058, 1739, 668, 1968, 1701, 1691, 1042, 1329, 1155, 1199, 1689, 1037, 1051, 1535, 1257, 985, 1014, 1378, 1039, 1605, 1413, 1623, 1432, 988, 1603, 796, 863, 115, 1649, 1606, 1648, 1609, 1612, 505, 1613, 1614, 1610, 1611, 1616, 1804, 1278, 1345, 715, 716, 363, 582, 1748, 1160, 1161, 1162, 464, 1122, 1452, 937, 1573, 948, 1744, 1760, 1216, 935, 1219, 924, 569, 922, 161, 966, 1280, 288, 1596, 895619, 423, 1571, 519, 1337, 596, 2933, 1597, 1669, 311, 1391, 388, 1053, 1127, 1167, 1186, 1351, 1331, 1204, 1091, 1327, 1778, 955, 1733, 1386, 1416, 1706, 1282, 1083, 1215, 1662, 1141, 1660, 1487, 1054, 993, 1033, 1357, 1421, 1390, 239, 2677, 1247, 1125, 1341, 1163 ****Serial Numbers Added 5/2/2025**** 1624, 1651, 76986, 634919, 93, 280, 311; (2) 764, 177, 905, 480, 499, 833, 787, 365, 169, 1336, 839, 1048, 343, 1011, 637, 917, 671, 677, 468, 1132, 670, 1025, 316, 1226, 411, 1108, 274, 1043, 1302, 160, 1309, 638, 1436, 527, 1442, 1109, 679, 119, 42, 467, 986, 987, 1112, 968, 791, 1084, 1440, 505, 286, 636, 946, 215, 214, 755, 1365, 809, 763, 992, 521, 932, 1123, 218, 1176, 67, 979, 1064, 127, 1209, 1210, 213, 624, 1298, 290, 190, 604, 605, 1126, 1173, 422, 1170, 882, 1128, 158, 646, 648, 395, 1396, 1233, 1234, 1235, 1236, 690, 698, 306, 478, 1041, 1042, 592, 1214, 780, 239, 1395, 1432, 830, 1082, 252, 873, 79, 818, 730, 1230, 1263, 69, 1370, 1369, 999, 43, 728, 485, 280, 488, 1310, 673, 683, 890, 641, 662, 1373, 1040, 308, 360, 1297, 567, 1028, 1397, 1398, 209, 500, 914, 1149, 794, 39, 423, 1118, 878, 920, 1005, 1275, 1292, 1144, 453, 364, 1425, 227, 792, 1283, 902, 1424, 229, 651, 240, 788, 296, 1312, 838, 1391, 1183, 611, 921, 939, 1344, 572, 970, 585, 1181, 1078, 1279, 656, 668, 896, 342, 531, 33, 344, 1308, 1069, 1287, 477, 1261, 937, 241, 298, 1009, 285, 1441, 694, 107, 414, 714, 785, 601, 654, 1122, 1198, 332, 777, 666, 301, 608, 426, 924, 577, 265, 1047, 1187, 219, 959, 901, 552, 1008, 888, 935, 1140, 64, 1213, 1015, 1016, 1017, 1018, 1194, 374, 1192, 1035, 524, 1153, 964, 996, 1188, 1208, 1190, 233, 1211, 418, 1116, 1168, 806, 50, 907, 887, 793, 400, 345, 825, 1339, 123, 508, 1351, 195, 289, 323, 1137, 713, 174, 173, 91, 53, 948, 1148, 502, 248, 1307, 45, 596, 187, 1304, 1001, 92, 602, 1346, 619, 1326, 134, 930, 302, 230, 232, 991, 245, 509, 1093, 1124, 1349, 176, 535, 370, 553, 941, 537, 712, 402, 1034, 1421, 748, 1368, 192, 1054, 1331, 447, 1367, 228, 393, 506, 1352, 856, 1191, 802, 803, 706, 369, 1375, 1381, 1389, 51, 1364, 264, 704, 613, 614, 238, 247, 350, 1206, 1253, 490, 1032, 928, 1325, 1380, 1258, 1165, 1390, 1394, 1285, 1215, 580, 1256, 722, 424, 971, 1254, 1384, 1378, 1379, 732, 1332, 425, 565, 541, 731, 1019, 1023, 391, 1360, 699, 759, 657, 658, 659, 854, 642, 993, 695, 696, 1252, 513, 1363, 1100, 1342, 1357, 707, 708, 1255, 1220, 734, 735, 736, 737, 469, 1366, 1321, 105, 1223, 1353, 1374, 898, 1098, 1099, 1113, 1350, 1327, 1361, 1376, 1356, 319, 1163, 1164, 1355, 603, 1003, 1242, 270, 267, 268, 831, 530, 1091, 940, 29, 63, 578, 884, 197, 1095, 322, 273, 146, 346, 126, 371, 1385, 622, 193, 412, 62, 483, 1161, 786, 1438, 1404, 1431, 1401, 1423, 310, 380, 1403, 685, 686, 1086, 1392, 46, 1445, 1402, 1345, 1151, 776, 1002, 799, 711, 990, 1125, 957, 520, 1245, 984, 1224, 1225, 771, 1036, 773, 282, 1268, 72, 715, 1221, 1010, 222, 1104, 978, 847, 340, 1434, 224, 663, 1087, 1433, 80, 653, 1371, 1393, 1083, 586, 1435, 1134, 1135, 911, 863, 1429, 1430, 253, 635, 1180, 398, 1004, 49, 533, 740, 625, 936, 163, 631, 1155, 1303, 620, 1056, 963, 1232, 1244, 496, 287, 299, 945, 915, 652, 471, 102, 162, 739, 128, 885, 297, 1315, 760, 1068, 401, 315, 795, 1177, 1178, 811, 600, 649, 692, 1050, 540, 655, 962, 961, 382, 828, 816, 212, 769, 28, 942, 610, 1241, 409, 1238, 136, 1150, 544, 944, 1427, 52, 650, 778, 300, 1111, 514, 249, 1196, 903, 1141, 1422, 1022, 164, 877, 255, 495, 758, 384, 1272, 1058, 801, 498, 797, 1145, 574, 1105, 1276, 1157, 1278, 97, 772, 415, 154, 1216, 1154, 615, 1273, 416, 1265, 1037, 954, 866, 427, 34, 35, 226, 967, 927, 1452, 969, 1169, 1294, 526, 895, 88, 955, 1444, 410, 1090, 1012, 703, 860, 86, 1202, 494, 275, 1166, 960, 1286, 861, 475, 1426, 356, 876, 1250, 157, 1428, 293, 37, 272, 139, 612, 1007, 1305, 1306, 1203, 1106, 83, 800, 383, 872, 98, 906, 989, 680, 1033, 733, 246, 261, 1021, 943, 665, 951, 832, 474, 1266, 1237, 333, 90, 720, 1039, 406, 1121, 837, 1120, 404, 1053, 428, 579, 503, 493, 211, 217, 351, 528, 559, 1334, 529, 138, 58, 566, 588, 589, 590, 591, 593, 594, 891, 949, 1146, 1267, 250, 199, 328, 75, 518, 568, 385, 122, 751, 70, 103, 104, 904, 700, 701, 106, 810, 850, 956, 1097, 842, 998, 77, 744, 182, 294, 1207, 1218, 855, 362, 1280, 1313, 587, 178, 874, 94, 1077, 466, 1300, 710, 972, 131, 1076, 934, 1130, 790, 858, 645, 1182, 276, 606, 116, 320, 997, 1065, 952, 548, 181, 753, 114, 562, 789, 1067, 1129, 975, 89, 523, 626, 243, 186, 1200, 223, 555, 598, 702, 1119, 1051, 137, 321, 338, 660, 741, 742, 1029, 1088, 1136, 95, 844, 973, 819, 1162, 142, 111, 561, 1000, 394, 1171, 269, 277, 304, 558, 822, 476, 852, 880, 1044, 132, 862, 804, 96, 396, 254, 330, 367, 473, 515, 909, 220, 1439, 373, 875, 112, 1152, 563, 900, 312, 313, 121, 1074, 1075, 807, 564, 1193, 762, 357, 1092, 1066, 834, 184, 857, 697, 634, 980, 1185, 1055, 782, 1096, 125, 225, 812, 813, 368, 913, 349, 354, 781, 235, 236, 549, 570, 388, 387, 386, 525, 251, 278, 868, 774, 1006, 1060, 516, 517, 403, 1030, 1031, 597, 492, 908, 845, 846, 507, 923, 687, 607, 817, 381, 60, 775, 78, 166, 501, 719, 185, 130, 1147, 141, 599, 689 ****Serial Numbers Added 5/2/2025**** 28, 60, 70, 75, 78, 112, 132, 246, 268, 289, 396; (3) 156, 253, 287, 825, 394, 713, 74, 462, 192, 191, 204, 155, 1132, 967, 205, 1246, 122, 259, 185, 618, 531, 855, 235, 805, 725, 832, 368, 646, 653, 663, 965, 602, 908, 959, 1129, 664, 778, 109, 110, 116, 117, 115, 284, 389, 841, 223, 694, 222, 374, 634, 622, 436, 878, 1192, 102, 914, 396, 704, 370, 782, 1210, 201, 774, 696, 838, 344, 563, 731, 233, 1126, 543, 93, 796, 1072, 601, 245, 234, 1340, 604, 627, 190, 605, 935, 11, 297, 560, 562, 98, 99, 100, 101, 1338, 1248, 544, 561, 1100, 765, 1239, 1293, 648, 1038, 1231, 1215, 215, 683, 142, 1268, 728, 1050, 600, 843, 391, 877, 224, 73, 608, 1051, 1052, 323, 324, 969, 444, 931, 265, 431, 114, 654, 786, 617, 87, 130, 990, 378, 1101, 558, 738, 1287, 942, 75, 688, 973, 985, 220, 781, 78, 845, 614, 151, 79, 559, 1205, 770, 909, 1000, 319, 633, 458, 381, 400, 826, 716, 966, 432, 335, 1068, 244, 957, 484, 485, 121, 612, 1049, 759, 866, 1115, 534, 807, 961, 962, 986, 638, 830, 707, 271, 998, 261, 89, 575, 180, 632, 594, 296, 257, 86, 488, 24, 354, 355, 619, 926, 729, 448, 535, 536, 159, 539, 1155, 90, 1092, 571, 626, 971, 28, 150, 525, 682, 194, 322, 1144, 700, 944, 377, 737, 1143, 811, 1173, 1195, 565, 763, 1168, 285, 379, 308, 306, 429, 300, 597, 598, 1028, 1176, 1187, 1035, 1174, 1351, 1282, 1314, 1315, 1153, 948, 760, 735, 930, 1312, 1122, 1311, 891, 806, 1164, 1214, 1294, 1336, 640, 641, 642, 756, 1161, 709, 767, 1346, 1354, 1352, 1109, 1256, 1296, 833, 1007, 1274, 1337, 1319, 1262, 1283, 1134, 1341, 1116, 1328, 1159, 1334, 984, 1076, 989, 1135, 1259, 1260, 1339, 1261, 1154, 579, 995, 1267, 1309, 1310, 1335, 1348, 1255, 1331, 1209, 1217, 1121, 1353, 1318, 1266, 1252, 1302, 1227, 1349, 1133, 1292, 1303, 636, 981, 1009, 1358, 1010, 1332, 939, 1270, 697, 859, 708, 1342, 1343, 1344, 1345, 1269, 1034, 128, 637, 29, 492, 464, 1273, 467, 1218, 327, 1156, 62, 153, 1301, 27, 330, 940, 1008, 1323, 913, 1330, 912, 1170, 918, 193, 917, 919, 916, 1325, 1031, 651, 809, 1326, 788, 695, 1320, 328, 1171, 84, 255, 1289, 397, 398, 679, 680, 1179, 7, 894, 420, 385, 69, 134, 581, 1091, 771, 745, 55, 276, 881, 65, 681, 77, 404, 146, 96, 343, 388, 107, 720, 721, 406, 979, 722, 342, 564, 609, 589, 623, 970, 247, 672, 216, 824, 170, 384, 773, 903, 292, 1234, 167, 1065, 603, 673, 888, 790, 758, 314, 95, 81, 200, 684, 304, 305, 606, 39, 262, 263, 383, 457, 1222, 251, 1157, 441, 686, 76, 42, 712, 1369, 1024, 1086, 1165, 780, 992, 468, 178, 365, 44, 938, 1178, 435, 82, 85, 710, 129, 592, 1245, 31, 163, 660, 523, 345, 118, 699, 844, 1219, 333, 338, 360, 730, 414, 551, 349, 727, 92, 519, 133, 208, 195, 196, 137, 419, 15, 599, 149, 445, 460, 528, 886, 887, 136, 529, 530, 821, 921, 983, 64, 1130, 293, 490, 994, 1188, 520, 452, 401, 1136, 405, 402, 631, 298, 493, 226, 423, 863, 814, 755, 237, 1125, 899, 225, 510, 358, 1203, 997, 97, 862, 334, 621, 616, 346, 1118, 332, 507, 715, 1152, 463, 785, 1372, 1019, 1106, 1104, 1020, 1058, 1048, 1370, 341, 762, 453, 1368, 742, 1308, 171, 299, 337, 357, 364, 382, 478, 325, 1037, 752, 310, 1278, 572, 1279, 1063, 1280, 1277, 1276, 1147, 1151, 517, 724, 1226, 362, 446, 956, 726, 1250, 574, 1316, 1047, 703, 1224, 854, 395, 1148, 1208, 689, 1046, 1022, 231, 433, 434, 447, 459, 567, 1149, 650, 840, 387, 509, 582, 557, 418, 279, 1023, 91, 376, 209, 403, 511, 210, 1066, 1078, 537, 927, 775, 988, 454, 897, 746, 591, 766, 776, 777, 541, 586, 901, 1067, 1018, 356, 868, 611, 596, 578, 813, 573, 754, 1321, 584, 701, 515, 177, 500, 812, 199, 132, 816, 274, 1184, 1105, 1169, 867, 869, 772, 714, 1120, 968, 810, 157, 311, 480, 610, 363, 1045, 896, 652, 508, 217, 662, 1102, 950, 1027, 937, 702, 1196, 516, 583, 580, 125, 498, 88, 361, 1163, 471, 661, 951, 275, 303, 590, 1371, 1150, 1281, 1062, 741, 1275, 898, 353, 1090, 249, 227, 1216, 1096, 1191, 1098, 476, 496, 139, 148, 214, 987, 421, 836, 1359, 1006, 740, 666, 943, 489, 625, 491, 1243, 487, 1240, 932, 649, 1185, 1190, 1044, 739, 1194, 761, 1241, 1242, 624, 393, 1021, 1097, 1070, 228, 269, 270, 372, 375, 425, 426, 427, 428, 449, 450, 472, 503, 687, 751, 753, 884, 902, 1026, 1029, 1113, 1123, 1199, 1305, 1329, 1355, 1356, 1360, 1361, 1362, 1363, 1364, 1366, 40, 1108, 1264, 1265, 14, 25, 570, 126, 164, 542, 566, 978, 1201, 1202, 127, 532, 889, 547, 706, 1365, 417, 206, 1206, 1207, 466, 442, 443, 105, 1357, 38, 870, 486, 70, 974, 106, 655, 669, 83, 160, 260, 211, 907, 198, 495, 1251, 793, 469, 268, 876, 568, 958, 1033, 1158, 975, 803, 184, 461, 895, 936, 1030, 1064, 1347, 677, 678, 827, 835, 252, 477, 1119, 815, 630, 188, 189, 1071, 900, 183, 22, 187, 152, 316, 317, 318, 277, 1317, 549, 13, 545, 808, 922, 288, 289, 470, 1145, 569, 1140, 1004, 779, 41, 723, 359, 577, 585, 873, 439, 440, 847, 250, 1053, 373, 336, 366, 390, 456, 505, 846, 819, 179, 506, 504, 213, 408, 1172, 278, 1162, 892, 286, 01H071046, 1257, 291, 588, 743, 540, 768, 784, 197, 527, 526, 1229, 1001, 628, 524, 266, 792, 656, 657, 658, 783, 119, 747, 410, 521, 348, 236, 875, 161, 182, 924, 928, 960, 1054, 1093, 1313, 692, 290, 412, 23, 411, 71, 857, 315, 789, 481, 430, 1271, 17, 18, 794, 294, 497, 911, 1228, 424, 769, 804, 494, 1249, 174, 172, 1146, 143, 748, 977, 273, 43, 1204, 1220, 1221, 587, 749, 203, 858, 1272, 141, 1107, 33, 347, 871, 880, 1012, 1013, 1014, 1015, 1016, 1177, 104, 256, 1230, 1131, 1011, 546, 1213, 1127, 1128, 1258, 1307, 1138, 1005, 1002, 818, 734, 147, 1327, 1137, 1306, 326, 732, 154, 659, 399, 736, 635, 416, 941, 1286, 166, 351, 1186, 593, 851, 212, 392, 313, 413, 502, 620, 675, 302, 1175, 719, 915, 1225, 1117, 1233, 1322 ****Serial Numbers Added 5/2/2025**** 86, 195, 196.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 2 of 20

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

Z-1143-2025
Recall number
Z-1143-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
590 units (141 US, 449 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 321, 435, 285, 384, 388, 340, 343, 399, 392, 565, 355, 367, 308, 348, 271, 530, 520, 323, 510, 49, 329, 365, 269, 270, 523, 490, 357, 346, 258, 298, 316, 485, 8095, 261, 2189, 352, 474, 497, 251, 63, 456, 360, 305, 419, 405, 489, 306, 307, 429, 447, 345, 342, 272, 531, 440, 441, 416, 116, 121, 136, 58, 561, 351, 52, CV.502, 478, 8, 55, 560, 341, 403, 25, 54, 354, 385, 26, 234, 287, 459, 469, 300, 494, 72, 76, 564, 754, 125, 519, 457, 373, 430, 499, 332, 508, 374, 85, 463, 464, 428, 500, 276, 359, 487, 538, 415, 328, 397, 366, 389, 378, 379, 371, 81, 511, 473, 209, 369, 543, 394, 507, 533, 482, 495, 333, 237, 339, 338, 467, 528, 53, 401, 325, 491 ****Serial Numbers Added 5/2/2025**** 63, 308, 8095, 8, 81, 116, 121, 136, 300, 325, 345. (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 124, 332, 102, 270, 177, 132, 325, 15, 76, 79, 17, 237, 255, 50, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 154, 215, 40, 328, 69, 374, 286, 81, 272, 293, 294, 224, 175, 117, 334, 338, 6, 146, 145, 355, 231, 323, 164, 151, 184, 266, 21, 80, 202, 165, 179, 367, 372, 203, 214, 369, 340, 18, 301, 302, 303, 304, 305, 306, 307, 318, 98, 211, 158, 271, 204, 246, 206, 321, 78, 295, 104, 217, 257, 265, 261, 253, 94, 225, 125, 38, 39, 176, 290, 291, 282, 216, 333, 329, 178, 127, 249, 230, 198, 244, 292, 180, 183, 314, 337, 201, 341, 376, 377, 378, 56, 259, 181, 317, 347, 287, 86, 300, 88, 309, 99, 233, 31, 156, 71, 222, 77, 188, 223, 238, 153, 51, 129, 68, 278, 118, 119, 186, 32, 108, 89, 258, 263, 41, 55, 310, 371, 66, 274, 139, 141, 227, 243, 296, 191, 220, 242, 166, 161, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 213, 212, 12, 115, 152, 111, 116, 113, 112, 114, 43, 277, 313, 26, 29 ****Serial Numbers Added 5/2/2025**** 87, 124, 172, 237, 31, 36, 51, 78, 113, 151, 161, 175, 179, 181, 191, 225, 243, 291, 296, 369, 371; (3) 203, 335, 123, 133, 134, 284, 280, 183, 106, 169, 107, 234, 42, 179, 101, 265, 306, 307, 209, 267, 153, 40, 332, 156, 112, 305, 1, 104, 231, 263, 342, 71, 255, 351, 175, 298, 120, 116, 174, 240, 241, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 160, 27, 64, 78, 98, 245, 221, 352, 99, 55, 6, 86, 360, 7, 145, 214, 102, 204, 44, 210, 254, 84, 228, 297, 268, 77, 114, 115, 142, 30, 79, 38, 85, 189, 181, 321, 343, 144, 177, 165, 225, 211, 201, 3, 246, 291, 217, 215, 73, 315, 68, 87, 304, 51, 308, 289, 355, 21, 23, 24, 90, 171, 45, 128, 34, 122, 220, 33, 137, 287, 163, 67, 88, 232, 150, 208, 96, 310, 143, 155, 20, 166, 198, 242, 243, 269, 239, 147, 139, 180, 91, 136, 191, 197, 118, 193, 59, 312, 309, 311, 69, 296, 119, 276, 278, 250, 65, 168, 206, 158, 218, 66, 329, 75, 19, 141, 62, 330, 219, 138, 121, 264, 227, 286, 18, 31, 272, 235, 131, 195, 28, 326, 192, 207, 199, 125, 233, 148, 149, 58, 271, 212, 184, 328, 362, 5, 46, 47, 236, 135, 275, 159, 316, 277, 249, 223, 270, 322, 100, 103, 110, 57, 63, 244, 274, 256, 273, 61, 348, 349, 350, 36, 151, 300, 299, 167, 247, 282, 60, 259, 81, 126, 130, 70, 188, 347, 213, 339, 358, 94, 154, 172, 35, 346, 294, 97, 196, 76, 95, 357, 345, 361, 323, 324, 292, 293, 187, 337, 334, 338, 238, 356, 170, 146, 53, 162, 48, 205, 182, 82, 260, 261, 117, 80, 113, 186, 132 ****Serial Numbers Added 5/2/2025**** 179, 231, 63, 77, 97, 98;

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 3 of 20

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

Z-1144-2025
Recall number
Z-1144-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
5,029 Units (1566 US, 3463 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722006, (2) 722012, (3) 722028; UDI-DI: (1) No UDI, (2) 00884838059054, (3) 00884838054202; Serial Numbers: (1) 2013, 2155, 1473, 2110, 1364, 2268, 172, 2324, 1637, 1881, 2229, 2533, 2158, 1774, 468, 813, 1477, 2051, 2462, 1352, 2562, 771, 1734, 1589, 1445, 1547, 929, 1414, 731, 2131, 635249, 2569, 1461, 914, 2097, 1890, 2281, 1896, 1762, 1764, 159, 774, 2198, 2009, 1629, 810, 1729, 2454, 1209, 1646, 1924, 1339, 2301, 1927, 1928, 1706, 1705, 2571, 2524, 1582, 972, 878, 2200, 1575, 707, 1761, 861, 2537, 722, 72246F, 1674122, 1730, 1936, 1490, 2045, 2536, 1338, 1659, 2610, 920, 1662, 1346, 1587, 1977, 2140, 664, 706, 1843, 1594, 1875, CV.381, 886, 2523, 2267, 2823014, 1583, 1585, 1520, 2126, 1856, 1941, 288, 2390, 1425, 1496, 862, 896, 2608, 1393, 2204, 2366, 2449, 2456, 2269, 2425, 2066, 1744, 1747, 1748, 1325, 1812, 2606, 641, 1728, 559, 1443, 2530, CV.271, 283, 1755, 1120, 889, 518, 1007, 1104, 1914, 1752, 2565, 848, 904, 1754, 1375, 1696, 843, 2021, 2195, 1723, 767, 2585, 1523, 1733, 1978, 2102, 1085, 18268, 1588, 806, 782, 1177, 587, 161, 1391, 1956, 638, 1387, 2027, 1601, 2561, 2256, 2070, 2002, 1627, 893, 2347, 2548, 2587, 2427, 1865, 2152, 1361, 91, 2430, 2028, 2312, 1711, 2003, 1370, 1484, 1564, 1534, 1987, 2054, 2283, 1888, 1854, 1407, 1641, 852, 853, 2062, 1366, 1604, 2568, 1169, 1114, 1115, 1116, 1127, 01H041985, 723, 2106, 2111, 2112, 1536, 1732, 1870, 1420, 1818, 1775, 1341, 1827, 849, 1550, 1359, 913, 674, 1720, 1476, 1766, 1446, 1908, 2326, 828, 2525, 1289, 1306, 830, 1781, 2296, 1972, 1932, 1935, 1273, 1502, 2201, 804, 1727, 1900, 2088, 1480, 1168, 1631, 1196, 1831, 2007, 2187, 797, 1328, 1922, 1384, 2443, 1844, 1848, 1611, 683, 2143, 1323, 778, 1081, 1466, 2336, 327, 1469, 1830, 38925, 1832, 1600, 775, 1654, 1707, 2459, 2297, 1639, 1153, 1167, 1615, 1833, 992, 1612, 1939, 2184, 1807, 1872, 2042, 2489, 2181, 1448, 1868, 1955, 1740, CV.514, 888, 2380, 2272, S4F621389A000001, 1050, 1511, 550, 2147, 1942, 2382, 1274, 1276, 1500, 1845, 1441, 1438, 658, 1518, 2250, 1780, 1326, 1259, 1913, 91A, 1731, 1000, 1653, 2203, 680, 1221, 2199, 1609, 599, 1921, 2135, 1886, 2378, 663, 1889, 2183, 1433, 80320, 2025, 2576, 1911, 1648, 1174, 1507, 1229, 1434, 2323, 1318, 1722, 1560, 1093, 1750, 2564, 1205, 781, 722008-358, 1236, 1710, 2058, 2161, 2612, 1603, CV.740, 1621, 1640, 1670, 2159, 1578, 1906, 602A, 1210, 1383, 2412, 1374, 2274, 2286, 1983, 1372, 1373, 1838, 1270, 1591, 2318, 1022, 1246, 1859, 2371, 1230, 1580, 1745, 1464, 1724, 2232, 2194, 2046, 2535, 2231, 1403, 2117, 2389, 2043, 958, 1861, 1224, 1113, 1255, 2173, 1402, 1712, 666, 2521, 589, 2236, 811, 1200, 1505, 2416, 1714, 1336, 2349, 1650, 1787, 2214, 1538, 1919, 854, 1899, 1204, 1106, 1961, 2150, 2255, 1506, 1651, 2392, 1808, 1815, 1463, 1814, 1678, 2039, 1840, 2144, 1991, 1819, 1880, 1985, 1307, 867, 1988, 1529, 2041, 2104, 1515, 1892, 2314, 2063, 1003, 2101, 2488, 2438, 1031, 1992, 1715, 2095, 1343, 2093, 1347, 1784, 955, 2094, 1284, 2115, 1530, 1759, 1344, 2245, 1280, 2067, 946, 1316, 1817, 2162, 2348, 1130, 1232, 2061, 833, 884, 2288, 2292, 1231, 1537, 1295, 1967, 2399, 873, 856, 2423, 1816, 1554, 1916, 1796, 812, 2237, 1763, 2307, 2064, 1561, 2244, 2361, 2004, 1793, 1617, 952, 837, 1285, 802, 1746, 1947, 2325, 1998, 1348, 2360, 2293, 1233, 2291, 2022, 1893, 2434, 1968, 887, 1849, 2137, 1065, 2369, 2109, 2192, 1004, 2393, 2305, 1948, 1777, 1513, 820, 951, 925, 2080, 2145, 2023, 971, 1997, 1647, 2428, 1704, 492, 2247, 2240, 1160, 1999, 1424, 2026, 1468, 1198, 1253, 2015, 2555, 2368, 2553, 2538, 2034, 2550, 1427, 533, 2551, 1337, 2584, 922, 1794, 2090, 164, 2514, 880, 1791, 2419, 1602, 1824, 1397, 1980, 1823, 1668, 2526, 2426, 2552, 2465, 2541, 2529, 491, 585, 86, 1632, 63, 2171, 973, 1590, 1598, 2285, 1795, 2049, 1949, 1595, 2079, 1568, 1392, 2206, 2343, 2411, 2124, 1349, 1454, 1455, 1456, 1751, 2031, 963, 1658, 885, 2153, 2310, 931, 2010, 1749, 2275, 1225, 1549, 2353, 940, 1330, 1952, 2379, 2598, 640, 936, 2136, 2367, 1545, 2209, 2600, 890, 2493, 2375, 602, 799, 1540, 1556, 1345, 2096, 866, 1969, 1542, 1933, 2259, 296, 1876, 2217, 2085, 1021, 1452, 2103, 1552, 1460, 1917, 1667, 2038, 1222, 2520, 1180, 2475, 2176, 1686, 1687, 2129, 2342, 8, 1075, 2086, 689, 1509, 1708, 2175, 2179, 808, 1401, 2163, 1080, 1149, 1533, NL94, 1219, 1220, 724, 1965, 2154, 2230, 1773, 1858, 2182, 2334, 1618, 1990, 1811, 1129, 2132, 1405, 1771, 1864, 1281, 1296, 2165, 1250, 1757, 1488, 2166, 2290, 1056, 520, 1738, 617, 1690, 717, 609, 1925, 819, 2040, 2069, 2211, 1478, 687, 2531, 1079, 1524, 1851, 1753, 2528, 1492, 578, 2532, 989, 1517, 2527, 1440, 2243, 2580, 2517, 1423, 636, 1557, 1408, 990, 1312, 2225, 618, 794, 1741, 2391, 1758, 2373, 2014, 2114, 1802, 1525, 2219, 2228, 1801, 2248, 2279, 1871 ****Serial Numbers Added 5/2/2025**** 296, 1674122, 38925, 2576, 2122, 1972, 1812, 1775, 1722, 1705, 1461, 1434, 1325, 1210, 1205, 1196, 1167, 1153, 896, 813; (2) 2353, 919, 1581, 1117, 1673, 1712, 585, 2876, 517, 1545, 70, 1715, 504, 757, 935, 1356, 1250, 1613, 2006, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 92, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 1659, 494, 335, 1804, 1473, 100, 1408, 1401, 1588, 576, 595, 590, 2302, 2508, 2511, 1279, 2509, 452, 2151, 1724, 1609, 2896, 2134, 481, 348, 543, 893, 1187, 1455, 2085, 2202, 423, 718, 1282, 325, 2723, 2697, 2721, 2722, 2726, 796, 2890, 525, 2307, 1798, 1656, 399, 990, 2693, 1806, 1871, 2506, 2518, 243, 951, 1652, 2883, 894, 1597, 596, 1054, 1189, 1099, 823, 1037, 566, 72, 1606, 924, 2310, 2713, 1610, 686, 2933, 2514, 1108, 2829, 1294, 568, 500, 459, 469, 2886, 2760, 1077, 440, 1422, 1537, 2875, 2888, 1035, 285, 84, 1317, 1649, 1895, 1900, 1723, 878, 2221, 2496, 2311, 2222, 1515, 2828, 1803, 2484, 1731, 1017, 1020, 380, 1811, 527, 2171, 1497, 782, 418, 1053, 1558, 1336, 601, 1014, 684, 1265, 331, 389, 732, 751, 1324, 2276, 2086, 1285, 2219, 2687, 298, 814, 815, 1120, 278, 297, 1713, 1506, 1098, 1852, 1307, 1858, 377, 758, 1598, 2912, 172, 2054, 856, 1690, 1407, 480, 690, 579, 1327, 695, 1207, 1036, 2740, 733, 1091, 1254, 797, 213, 735, 1280, 2138, 828, 2821, 1118, 740, 1249, 542, 1033, 2265, 2935, 490, 470, 1075, 2203, 2774, 1321, 1396, 606, 444, 66, 2092, 597, 1269, 67, 244, 1002, 1022, 1023, 2264, 2234, 1805, 1192, 1823, 483, 484, 615, 2150, 2899, 892, 1478, 1262, 1688, 1961, 1732, 1062, 649, 650, 767, 2657, 1104, 1641, 1277, 2609, 1975, 276, 316, 959, 1335, 1461, 159, 489, 766, 639, 669, 671, 1583, 451, 625, 2692, 651, 1047, 107, 1447, 99, 670, 676, 124, 1616, 1660, 1083, 1807, 1924, 511, 1714, 122, 101, 75, 1406, 352, 492, 472, 642, 643, 1270, 577, 578, 1306, 855, 1456, 2269, 71, 1078, 768, 2285, 1793, 1797, 1216, 948, 387, 498, 1570, 2521, 1662, 104, 1868, 2313, 1743, 369, 2516, 1239, 1561, 464, 2286, 2293, 2901, 1960, 616, 1508, 1084, 2289, 1038, 1058, 318, 655, 1796, 1026, 2629, 1337, 685, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 531, 1586, 1617, 1904, 1354, 1918, 1906, 160, 383, 560, 68, 2755, 2614, 114, 1948, 1195, 518, 888, 1329, 1992, 323, 792, 1003, 1219, 2898, 89, 115, 2003, 2004, 2835, 2843, 135, 174, 1832, 2133, 2166, 562, 1941, 760, 859, 1593, 1608, 1947, 1950, 731, 520, 848, 2292, 2656, 1946, 274, 1063, 611, 1587, 1226, 613, 1271, 1842, 205, 2736, 1799, 1665, 187, 1513, 2889, 2868, 2869, 2015, 2207, 2840, 2841, 2842, 2849, 2309, 319, 2161, 1116, 691, 1993, 208, 943, 2873, 150, 1281, 1945, 1919, 110, 337, 1735, 1326, 788, 488, 2002, 132, 1218, 1519, 1533, 336, 694, 1334, 2013, 1405, 1141, 923, 925, 533, 406, 2741, 1293, 513, 2712, 1446, 1625, 1675, 1683, 1148, 1181, 207, 442, 1305, 790, 499, 1726, 85, 476, 1657, 1531, 1630, 2610, 851, 1827, 277, 1923, 1516, 2677, 404, 453, 321, 334, 197, 1869, 2215, 2857, 574, 1611, 2874, 1559, 2924, 1686, 2855, 2856, 1635, 858, 1224, 1345, 86, 2057, 1430, 2696, 1255, 1599, 302, 610, 1209, 920, 666, 1989, 2844, 2014, 2022, 1126, 1549, 1943, 1188, 1073, 1404, 1664, 103, 1272, 2063, 2319, 594, 1467, 1596, 2607, 326, 926, 675, 756, 1027, 424, 1894, 2145, 2146, 2148, 234, 2065, 1527, 1477, 2227, 2900, 1177, 1645, 2522, 2735, 93, 1167, 1595, 2469, 88, 1672, 1210, 1512, 1101, 787, 1399, 123, 126, 136, 2658, 1119, 2655, 952, 953, 954, 1005, 1661, 2156, 320, 570, 2707, 1622, 1115, 1316, 1212, 975, 976, 1032, 986, 971, 1594, 233, 239, 640, 446, 2929, 69, 1301, 2254, 2323, 430, 1542, 76, 1607, 2454, 2149, 1211, 1004, 2046, 974, 2305, 1044, 2881, 505, 2937, 310, 192, 314, 852, 2930, 224, 1016, 2645, 2653, 1097, 1532, 1964, 2135, 1357, 589, 1092, 248, 846, 963, 964, 1658, 412, 1344, 1902, 328, 781, 1909, 1132, 1361, 1504, 1433, 229, 142, 962, 1260, 2108, 1094, 837, 333, 1681, 2282, 1815, 922, 1333, 774, 1492, 2047, 1655, 1855, 1817, 309, 1052, 1994, 1428, 1562, 627, 2005, 930, 1956, 967, 2168, 910, 1168, 167, 931, 2098, 1421, 1802, 632, 137, 957, 863, 289, 1040, 409, 1072, 1332, 2042, 57, 995, 993, 516, 2350, 759, 350, 1460, 1872, 1971, 550, 2107, 914, 2352, 1156, 180, 2314, 1464, 347, 2335, 139, 795, 1865, 628, 583, 809, 194, 170, 2406, 861, 351, 1291, 2244, 2169, 482, 1363, 1457, 288, 553, 462, 1980, 203, 1580, 395, 1423, 548, 2455, 1887, 2456, 1157, 1485, 2744, 876, 1592, 582, 2346, 2747, 2074, 2072, 1256, 2743, 2714, 166, 746, 2631, 2418, 436, 2386, 1214, 2749, 2674, 2739, 2196, 619, 199, 1833, 2587, 2032, 630, 2584, 1825, 1839, 1591, 261, 291, 2578, 2462, 502, 60, 2547, 2548, 381, 2333, 1986, 2599, 98, 1196, 1495, 2485, 2139, 2490, 477, 2200, 779, 2734, 56, 2331, 2385, 296, 2756, 770, 507, 727, 799, 279, 992, 2813, 1413, 58, 128, 392, 541, 1480, 2553, 2545, 978, 2356, 2784, 1297, 2026, 652, 1150, 59, 1349, 911, 152, 2450, 2585, 215, 871, 2640, 2790, 2830, 1678, 2683, 2729, 2029, 2413, 2451, 2622, 1228, 2071, 2076, 2127, 1671, 2737, 1081, 1298, 1028, 2771, 2056, 1366, 1708, 2775, 275, 830, 2479, 1978, 2579, 1244, 829, 2659, 2363, 891, 2102, 2300, 663, 2675, 2474, 2757, 839, 91, 2298, 1151, 1152, 2565, 1626, 2403, 1882, 569, 688, 2016, 2780, 2181, 2296, 544, 1481, 338, 2797, 1390, 2473, 419, 2504, 2197, 1436, 2336, 728, 785, 355, 1698, 165, 793, 794, 1556, 1654, 1801, 2539, 1736, 2601, 2702, 2604, 2758, 1967, 2096, 622, 210, 2678, 2365, 2837, 2366, 2291, 2299, 2665, 2501, 1878, 2811, 1669, 2634, 648, 1471, 2704, 2765, 737, 1879, 581, 1397, 2121, 1937, 2661, 2388, 382, 2180, 1342, 647, 1818, 2673, 2786, 2651, 867, 1816, 1288, 1489, 2725, 1178, 2544, 1874, 2911, 2349, 2724, 2175, 479, 2537, 2176, 1175, 1237, 2691, 1381, 2538, 2274, 2715, 398, 2523, 2491, 2763, 2785, 2459, 2716, 1965, 2160, 941, 211, 1147, 1303, 803, 1699, 1130, 798, 441, 1089, 2272, 2429, 2788, 1463, 1479, 2685, 534, 1138, 1203, 1828, 2401, 752, 2824, 2738, 870, 2344, 1536, 2249, 2612, 2532, 2410, 772, 2781, 2120, 1021, 1382, 2441, 2326, 2345, 1999, 2405, 2766, 1309, 2438, 1739, 1572, 2173, 2174, 1836, 2558, 2343, 2826, 2831, 680, 980, 2058, 2568, 1142, 2770, 2549, 1263, 2695, 2583, 730, 2031, 1976, 2118, 2810, 1079, 1530, 1875, 593, 2649, 2394, 1808, 2527, 1412, 506, 1548, 2384, 280, 2718, 2153, 748, 188, 2140, 2576, 2476, 2666, 1567, 2411, 2431, 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2452, 1926, 2821, 2596, 2884, 2285, 2105, 1455, 2045, 1780, 1648, 2554, 2887, 2503, 2546, 1193, 2048, 2075, 2040, 1790, 2527, 2481, 2483, 1915, 2309, 2395, 2733, 1090, 2785, 2786, 1196, 2387, 2270, 1536, 2649, 2122, 2313, 2047, 1575, 2487, 2378, 1246, 2940, 2203, 2116, 1972, 2410, 1252, 2077, 2594, 2881, 2051, 2894, 1470, 2804, 2474, 2914, 2865, 510, 1753, 1357, 2536, 931, 2864, 2363, 2849, 2227, 1732, 1401, 2743, 1208, 2560, 2668, 603, 604, 2913, 1663, 2137, 1227, 2260, 2772, 2237, 2770, 1768, 2719, 2692, 2409, 2567, 876, 1767, 2204, 2205, 2671, 2741, 796, 2853, 711, 2750, 1497, 2119, 1505, 2115, 2736, 1968, 2100, 2346, 2685, 2354, 2683, 2686, 1206, 1377, 1552, 2848, 1770, 2141, 1534, 2188, 2858, 1217, 708, 2814, 2589, 1216, 2656, 2108, 2530, 2329, 2523, 1881, 2653, 1166, 1065, 2214, 1500, 2633, 1543, 1153, 1674, 1539, 1998, 2396, 2397, 2267, 2861, 1289, 1096, 2910, 2915, 1760, 815, 2421, 1670, 1671, 1682, 2521, 2081, 2574, 1976, 755, 1665, 1921, 2161, 2528, 1106, 2234, 2775, 2586, 2776, 1912, 2687, 2688, 1019, 1943, 2403, 2404, 2779, 2911, 2912, 1944, 1245, 615, 2514, 1679, 2212, 2532, 1795, 2925, 1899, 1821, 1806, 1908, 2282, 2697, 2698, 2691, 2034, 2186, 2777, 1044, 2093, 1882, 988, 2932, 2763, 2796, 1959, 2418, 2138, 2588, 2737, 2738, 2878, 2086, 2587, 2877, 2195, 2643, 2162, 2783, 2781, 2782, 943, 1464, 1885, 2130, 2476, 2477, 2839, 1902, 2708, 1571, 2271, 2902, 2903, 1962, 1295, 2021, 1427, 1804, 2165, 2095, 2828, 2193, 2576, 1725, 2263, 2213, 2326, 2003, 2091, 2120, 1728, 2854, 2545, 1990, 2835, 1429, 507, 508, 2895, 2531, 2258, 1574, 735, 736, 737, 1496, 1578, 1579, 1356, 1358, 1960, 2612, 2456, 2129, 1973, 1163, 2226, 2465, 2304, 2305, 2306, 838, 2954, 2265, 2343, 2670, 2879, 1726, 2923, 2744, 2958, 2844, 2438, 2513, 1117, 2957, 2811, 2847, 1521, 2809, 1061, 2936, 1542, 2563, 2458, 2092, 2297, 1642, 2758, 2896, 1900, 1831, 2606, 969, 1251, 2525, 1892, 2318, 2765, 1884, 2735, 2485, 2908, 1581, 1584, 2720, 2498, 2033, 2338, 1510, 2718, 2771, 2871, 1194, 1843, 2468, 2680, 2472, 1825, 1970, 2790, 2731, 2413, 2085, 2939, 2605, 1403, 2613, 2365, 1913, 2236, 2238, 2559, 1958, 907, 2634, 1415, 2197, 2319, 1717, 1886, 2780, 1409, 2553, 2331, 2006, 1026, 2144, 2268, 2722, 2517, 1240, 2269, 2693, 2623, 2694, 2695, 2747, 2225, 2808, 2480, 2866, 1158, 2166, 2154, 2330, 2187, 2526, 2352, 2886, 1325, 2027, 2755, 2764, 2283, 2852, 2949, 984, 612, 323, 853, 1082, 126, 1857, 1369, 201, 555, 702, 304, 321, 1027, 933, 415, 1487, 1488, 1932, 1577, 9, 271, 104, 38, 578, 2168, 1688, 414, 413, 13, 1911, 986, 765, 112, 824, 985, 120, 221, 512, 374, 1443, 661, 980, 164, 1347, 181, 1703, 1669, 101, 574, 747, 635, 91, 862, 514, 412, 182, 277, 1551, 330, 480, 511, 894, 232, 1332, 816, 400, 193, 780, 49, 575, 813, 709, 926, 616, 178, 233, 812, 244, 1287, 32, 1400, 35, 1979, 1104, 40, 881, 1337, 799, 163, 641, 766, 776, 1219, 1285, 297, 434, 389, 1101, 380, 624, 676, 119, 441, 1205, 1937, 105, 111, 687, 523, 2076, 576, 577, 43, 954, 192, 1907, 810, 1128, 899, 179, 1309, 54, 472, 1112, 295, 745, 123, 1207, 1307, 1308, 455, 1712, 2609, 718, 51, 777, 1517, 1735, 831, 689, 188, 730, 839, 1180, 492, 1388, 2256, 1587, 1362, 762, 1321, 851, 568, 1047, 1986, 392, 856, 1363, 2024, 1947, 1480, 1638, 1159, 1866, 168, 1097, 1025, 1438, 1184, 1596, 162, 716, 613, 857, 1580, 852, 1209, 337, 609, 1608, 1231, 1141, 249, 921, 1616, 1399, 1092, 544, 1433, 2426, 1618, 2292, 1515, 1617, 1597, 1479, 1612, 2038, 2058, 2614, 1525, 2059, 1417, 1610, 270, 1404, 1605, 1626, 1582, 970, 81, 527, 937, 1529, 767, 800, 826, 1021, 1235, 1329, 1462, 2314, 2598, 941, 2555, 1426, 2467, 2620, 2478, 2570, 2618, 1432, 679, 1045, 2621, 301, 150, 156, 2617, 919, 606, 557, 2294, 593, 594, 1548, 1361, 2101, 483, 1858, 2585, 732, 2632, 1134, 1135, 2622, 1265, 395, 1037, 98, 893, 673, 103, 622, 1996, 354, 1714, 657, 599, 693, 1257, 517, 752, 366, 1975, 633, 2199, 1550, 276, 1453, 403, 947, 898, 285, 649, 2065, 605, 427, 246, 334, 74, 653, 245, 532, 648, 199, 1210, 2153, 442, 1391, 444, 27, 1442, 1792, 484, 302, 335, 795, 773, 338, 2572, 659, 660, 863, 2019, 1418, 10, 1067, 972, 115, 640, 1271, 1066, 1458, 1895, 602, 935, 198, 290, 2400, 814, 341, 1813, 1635, 1636, 191, 1743, 1812, 2222, 875, 482, 1302, 782, 939, 617, 100, 1165, 186, 1583, 1071, 1075, 794, 432, 965, 614, 764, 501, 1695, 1694, 1704, 1693, 1313, 1312, 367, 1702, 1700, 545, 438, 1123, 1124, 832, 286, 820, 29, 802, 1258, 99, 398, 214, 665, 817, 23, 328, 608, 1064, 1320, 1089, 1070, 1621, 37, 1545, 1421, 2172, 439, 1178, 423, 235, 1632, 433, 2098, 322, 868, 1133, 1073, 694, 1346, 219, 754, 175, 202, 1221, 1105, 798, 642, 670, 727, 725, 387, 726, 722, 621, 724, 723, 2112, 1982, 2189, 1788, 2171, 974, 259, 643, 34, 1170, 2029, 314, 1297, 1799, 860, 2150, 458, 756, 1684, 410, 269, 1241, 296, 705, 703, 704, 707, 1557, 2074, 1102, 1715, 1731, 2026, 2170, 2190, 226, 1740, 847, 1918, 1625, 1685, 1118, 623, 597, 355, 1183, 2073, 291, 311, 266, 792, 1559, 1558, 551, 116, 790, 611, 1120, 79, 170, 171, 1604, 1602, 1601, 1603, 65, 753, 830, 1195, 352, 320, 2102, 690, 600, 701, 1181, 411, 1675, 153, 309, 778, 650, 662, 912, 1151, 397, 562, 353, 1152, 1952, 1148, 585, 651, 652, 248, 1815, 362, 1079, 1293, 1186, 348, 1437, 1386, 738, 369, 319, 1157, 230, 1546, 1547, 2143, 506, 2035, 1268, 77, 801, 370, 2364, 443, 183, 713, 1242, 964, 504, 187, 1914, 1789, 327, 658, 157, 883, 884, 287, 2090, 1125, 685, 834, 1893, 797, 1689, 1040, 1713, 1411, 2324, 1709, 1718, 1928, 2194, 2273, 429, 225, 588, 1879, 1389, 2099, 41, 1029, 360, 1562, 2274, 278, 1328, 1419, 955, 783, 1364, 1367, 14, 1637, 107, 124, 469, 775, 1757, 502, 2246, 1372, 388, 381, 1018, 975, 465, 803, 733, 113, 573, 844, 845, 846, 1720, 2025, 1686, 1314, 2107, 2492, 1786, 1687, 1810, 712, 1785, 2491, 1425, 714, 1613, 36, 1173, 2494, 2490, 843, 2217, 1280, 2547, 1247, 2489, 149, 2043, 1063, 2496 ****Serial Numbers Added 5/2/2025**** 305, 347, 488, 734, 909, 966, 977, 1024, 1256, 1522, 1945, 51, 59, 65, 144, 202, 246, 271, 304, 396.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 4 of 20

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

Z-1145-2025
Recall number
Z-1145-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
479 units (186 US, 293 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722008, (2) 722013; UDI-DI: (1) No UDI, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 312, 319, 516, 244, 453, 306, 378, 124, 18270, 524, 463, 197, 264, 294, 246, 320, 357, 212, 459, 472, 483, 465, 419, 38, 454, 441, 460, 369, 407, 231, 437, 105, 420, 1178, 270, 442, 521, 372, 254, 365, 390, 413, 379, 18, 239, 288, 424, 279, 481, 304, 267, 361, 415, 245, 445, 296, 487, 349, 456, 470, 386, 37, 205, 371, 416, 339, 513, 355, 337, 476, 121, 169, 327, 289, 518, 242, 93, 542, 122, 376, 543, 87, 391, 499, 253, 259, 393, 447, 495, 250, 110, 273, 31, 553, 433, 63, 398, 546, 213, 356, 408, 404, 448, 305, 475, 6001385, 425, 435, 450, 480, 370, 167, 323, 247, 525, 455, 394, 160, 350, 406, 274, 388, 283, 359, 8, 346, 335, 458, 410, 367, 266, 268, 482, 272, 385, 290, 468, 446, 46, 334 ****Serial Numbers Added 5/2/2025**** 378, 379, 516, 242, 274, 335, 367, 371, 393; (2) 505, 217, 313, 113, 34, 153, 410, 360, 290, 74, 83, 580, 160, 404, 126, 244, 106, 346, 383, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 214, 402, 86, 603, 82, 149, 424, 140, 254, 255, 266, 475, 518, 519, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 73, 264, 78, 268, 308, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 379, 84, 125, 241, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 35, 480, 304, 634, 147, 15, 607, 52, 567, 283, 168, 171, 265, 509, 332, 272, 295, 97, 589, 444, 447, 292, 400, 628, 384, 206, 559, 538, 117, 629, 620, 624, 623, 215, 454, 416, 415, 47, 335, 222, 619, 598, 445, 361, 358, 549, 133, 476, 315, 36, 31, 390, 630, 17, 633, 417, 490, 48, 528, 53, 238, 525, 276, 560, 157, 247, 618, 372, 224, 76, 613, 478, 50, 544, 172, 232, 530, 349, 585, 608, 66, 296, 271, 359, 570, 457, 547, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 107, 138, 225, 58, 29, 227, 318, 345, 139, 473, 388, 434, 64, 502, 586, 394, 275, 334, 411, 501, 450, 208, 408, 458, 258, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 103, 396, 551, 250, 595, 406, 510, 355, 57, 535, 137, 569, 522, 436, 465, 201, 533, 135, 412, 95, 294, 344, 354, 425, 542, 207, 622, 182, 555, 524, 574, 366, 527, 324, 311, 459, 70, 161, 449, 321, 176, 65, 181, 554, 104, 167, 312, 130, 325, 470, 440, 144, 28, 385, 403, 448, 81, 380, 374, 256, 405, 60, 108, 468, 367, 455, 191, 301, 302, 352, 62, 300, 299, 71, 239, 506, 243, 378, 632, 110, 111, 158, 237, 453, 165, 364, 532, 223, 343, 291, 22, 370, 193, 163, 526, 236, 132, 156, 368, 177, 443, 259, 540 ****Serial Numbers Added 5/2/2025**** 35, 72, 73, 82, 113, 160, 480, 580, 76, 97, 272, 292, 396.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 5 of 20

Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

Z-1146-2025
Recall number
Z-1146-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
3 units (2 US, 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722020, (2) 722025; UDI-DI: (1) No UDI, (2) 00884838059108; Serial Numbers: (1) 6; (2) 2, 3.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 6 of 20

Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

Z-1147-2025
Recall number
Z-1147-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
2 units (1 US, 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722023, (2) 722035; UDI-DI: (1) 00884838059085, (2) 00884838054240; Serial Numbers: (1) 175; (2) 208.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 7 of 20

Allura Xper FD20/10; Catalog numbers: 722029

Z-1148-2025
Recall number
Z-1148-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
87 units (22 US, 65 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog number: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 84, 95, 126, 110, 56, 55, 57, 31, 119, 87, 93, 24, 32, 39, 34, 14, 122, 127, 45, 48, 37, 23, 44, 40, 66, 38, 98, 75, 35, 89, 82, 61, 53, 25, 58, 33, 85, 27, 46, 19, 29, 20, 92, 52, 104, 70, 65, 109, 78, 96, 26, 59, 118, 108, 49, 50, 51, 128, 107, 114, 124, 103, 106, 81, 80, 47, 123, 116, 101, 79, 120, 43, 102.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 8 of 20

Allura Xper FD20/15; Catalog numbers: 722058

Z-1149-2025
Recall number
Z-1149-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
302 units (69 US, 233 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog number: 722058; UDI-DI: 00884838059115; Serial Numbers: 172, 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 340, 366, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 35, 108, 32, 161, 6, 49, 89, 18, 19, 336, 392, 416, 398, 399, 412, 379, 333, 418, 385, 331, 413, 419, 400, 421, 395, 394, 408, 380, 409, 393, 369, 360, 389, 356, 357, 382, 415, 358, 411, 387, 335, 381, 370, 422, 407, 423, 397, 367, 396, 404, 420, 66, 163, 211, 214, 55, 40, 133, 114, 72, 96, 15, 9, 39, 150, 25, 81, 84, 119, 177, 268, 3, 60, 131, 377, 164, 7, 206, 101, 246, 384, 220, 261, 244, 348, 233, 106, 229, 223, 145, 136, 137, 288, 76, 86, 179, 112, 351, 130, 166, 276, 237, 45, 210, 181, 33, 251, 144, 64, 79, 29, 113, 21, 102, 36, 266, 295, 245, 243, 16, 41, 242, 187, 10, 345, 218, 361, 90, 193, 70, 26, 194, 53, 153, 234, 34, 235, 247, 272, 195, 87, 43, 31, 221, 75, 20, 330, 208, 189, 303, 63, 37, 117, 73, 230, 116, 148, 284, 236, 98, 95, 240, 350, 169, 376, 313, 343, 241, 192, 185, 115, 375, 154, 327, 92, 334, 232, 151, 201, 269, 332, 292, 142, 256, 391, 128, 344, 226, 141, 78, 183, 125, 126, 320, 248, 77, 368, 315, 68, 139, 311, 67, 347, 222, 93, 213, 354, 355, 58, 143, 301, 170, 159, 30, 103, 88, 386, 349, 252, 388, 11, 372, 281, 204, 127, 258, 289, 291, 293, 27, 97, 48, 188, 273,

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 9 of 20

Allura Xper FD20/20; Catalog numbers: 722038

Z-1150-2025
Recall number
Z-1150-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
114 units (33 US, 81 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog number: 722038; UDI-DI: 00884838054226; Serial Numbers: 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49, 119, 126, 173, 37, 38, 48, 62, 35, 137, 120, 41, 157, 96, 70, 46, 102, 153, 155, 171, 172, 163, 129, 161, 122, 156, 121, 168, 113, 169, 160, 152, 162, 164, 148, 159, 144, 111, 138, 158, 124, 140, 154, 147, 14, 166, 127, 94, 95, 90, 91, 93, 143, 92, 89, 150, 88, 34, 136, 66, 30, 58, 29, 54, 170, 28, 47, 36, 79, 98, 31, 146, 3, 123, 32, 5, 9, 27, 105, 69, 40, 75, 11, 104, 112, 50, 116, 73, 133, 110, 72, 117, 134, 135, 68, 64, 45, 109.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 10 of 20

Allura CV20; Catalog numbers: 722031

Z-1151-2025
Recall number
Z-1151-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
111 units (OUS ONLY)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog number: 722031; UDI-DI: no UDI; Serial Numbers: 155, 42, 13, 150, 87, 154, 29, 73, 88, 48, 109, 78, 53, 17, 63, 11, 97, 138, 86, 39, 36, 152, 135, 49, 18, 15, 91, 41, 20, 64, 9, 40, 55, 23, 71, 35, 33, 32, 30, 76, 70, 25, 133, 101, 128, 173, 124, 84, 92, 166, 26, 61, 130, 89, 90, 116, 117, 110, 111, 112, 113, 177, 164, 165, 161, 162, 163, 28, 100, 174, 167, 168, 119, 50, 24, 185, 126, 149, 147, 146, 140, 79, 127, 66, 137, 65, 38, 169, 121, 122, 123, 148, 184, 62, 170, 159, 125, 131, 151, 178, 181, 158, 157, 134, 46, 136, 96, 45, 180, 47, 99, 54, 115, 31, 175, 83, 77, 94, 85,

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 11 of 20

Allura Xper FD10C; Catalog number: 722001

Z-1152-2025
Recall number
Z-1152-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
1 unit (OUS ONLY)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog number: 722001; UDI-DI: no UDI; Serial Number: 283

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 12 of 20

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

Z-1153-2025
Recall number
Z-1153-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
263 units (26 US, 237 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722063, (2) 722221; UDI-DI: (1) 00884838085275, (2) 00884838099203; Serial Numbers: (1) 96, 122, 132, 131, 108, 84, 98, 56, 64, 101, 29, 139, 61, 75, 40, 77, 123, 154, 137, 150, 144, 135, 145, 127, 53, 121, 148, 55, 99, 143, 43, 25, 54, 151, 91, 85, 90, 86, 107, 89, 88, 44, 76, 47, 83, 93, 2, 130, 23, 73, 41, 97, 116, 117, 19, 50, 24, 149, 102, 38, 92, 72, 46, 27, 21, 78, 63, 119, 128, 28, 129, 22, 141, 69, 115, 100, 113, 106, 14, 16, 17, 70, 153, 18, 120, 105, 80, 146, 94, 104, 26, 51, 15, 59, 103, 81, 133, 48, 52, 79, 140, 3, 4, 110, 62, 30, 82, 71, 36, 37; (2) 108, 9, 54, 19, 153, 181, 6, 3, 7, 49, 115, 177, 85, 93, 171, 69, 182, 2, 60, 86, 122, 105, 44, 71, 159, 187, 8, 127, 59, 56, 126, 1, 52, 68, 145, 107, 128, 74, 97, 91, 132, 114, 130, 172, 35, 82, 134, 22, 162, 95, 67, 51, 66, 84, 61, 46, 102, 50, 53, 78, 79, 149, 99, 27, 157, 48, 32, 31, 158, 151, 141, 94, 146, 104, 119, 135, 124, 57, 161, 184, 25, 40, 77, 92, 131, 76, 163, 81, 73, 41, 29, 123, 75, 47, 83, 28, 143, 183, 45, 33, 142, 118, 30, 16, 10, 169, 39, 64, 98, 129, 164, 103, 140, 38, 154, 62, 173, 180, 168, 13, 120, 152, 165, 34, 58, 174, 11, 185, 55, 70, 106, 147, 5, 15, 155, 166, 176, 42, 96, 36, 4, 43, 23, 26, 133, 167, 144, 101 ***Serial Numbers Added 5/2/25*** 178 186, 190, 196, 197.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 13 of 20

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

Z-1154-2025
Recall number
Z-1154-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
735 units (42 US, 693 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 14 of 20

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

Z-1155-2025
Recall number
Z-1155-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
282 units (9 US, 273 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722227, (2) 722231(OUS ONLY); UDI-DI: (1) 00884838099227, (2) 00884838116740; Serial Numbers: (1) 276, 238, 264, 63, 88, 135, 261, 19, 62, 83, 171, 191, 240, 133, 100, 93, 202, 115, 46, 134, 56, 53, 151, 99, 55, 54, 157, 158, 28, 241, 234, 164, 82, 299, 32, 12, 16, 272, 72, 64, 242, 176, 95, 2, 286, 75, 145, 71, 262, 143, 36, 120, 112, 5, 6, 7, 74, 188, 253, 280, 40, 87, 102, 146, 147, 77, 122, 141, 14, 15, 4, 163, 47, 48, 3, 1, 13, 123, 86, 269, 92, 173, 174, 121, 204, 258, 126, 245, 231, 81, 199, 166, 308, 105, 124, 49, 31, 26, 108, 247, 287, 170, 61, 292, 183, 168, 197, 195, 194, 149, 138, 140, 43, 273, 21, 17, 210, 22, 37, 221, 218, 219, 114, 101, 217, 220, 111, 294, 59, 85, 160, 67, 148, 96, 30, 20, 29, 263, 196, 137, 84, 236, 198, 118, 304, 23, 172, 230, 38, 159, 187, 125, 73, 60, 203, 211, 91, 52, 226, 216, 161, 128, 44, 206, 233, 103, 243, 260, 80, 281, 154, 252, 127, 205, 180, 106, 79, 98, 104, 293, 110, 113, 109, 177, 248, 227, 94, 259, 229, 301, 222, 162, 153, 300, 107, 167, 200, 142, 90, 69, 251, 268, 290, 309, 310, 316, 256, 228, 57, 184, 116, 165, 282, 178, 11, 35, 209, 132, 131, 58, 130, 18, 8, 9, 215, 249, 41, 270, 179, 24, 285, 305, 250, 25, 298, 156, 76, 155, 65, 213, 192, 239, 315, 89, 175, 257, 246, 136, 307, 181 ****Serial Numbers Added 5/2/2025**** 265, 271, 360, 311, 313, 318, 319, 320, 321, 323, 324, 329, 330, 331, 332, 333, 334, 335, 337, 339, 346, 350, 352, 355. (2) OUS ONLY 2, 3. ****Serial Numbers Added 5/2/2025**** 1, 4, 5, 11, 20.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 15 of 20

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

Z-1156-2025
Recall number
Z-1156-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
632 units (77 US, 555 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722228, (2) 722232(OUS ONLY), (3) 722281 (OUS ONLY); UDI-DI: (1) 00884838099234, (2) 00884838116757, (3) no UDI; Serial Numbers: (1) 522, 187, 328, 113, 205, 204, 273, 180, 61, 523, 132, 149, 48, 79, 80, 37, 481, 17, 150, 32, 159, 23, 25, 29, 431, 127, 38, 87, 47, 24, 373, 91, 399, 10, 36, 6, 49, 211, 189, 231, 123, 124, 185, 186, 198, 213, 122, 64, 20, 157, 26, 110, 403, 529, 181, 177, 524, 573, 62, 128, 153, 45, 502, 215, 92, 67, 18, 76, 504, 395, 125, 391, 178, 229, 106, 56, 12, 408, 89, 194, 60, 193, 377, 190, 383, 464, 462, 138, 94, 309, 310, 93, 114, 145, 365, 311, 611, 629, 440, 368, 590, 591, 360, 421, 195, 501, 292, 364, 490, 352, 297, 386, 525, 448, 182, 473, 404, 503, 376, 534, 486, 487, 606, 196, 280, 166, 340, 438, 220, 212, 535, 362, 555, 607, 608, 302, 489, 424, 425, 183, 402, 405, 258, 320, 384, 434, 314, 306, 325, 497, 305, 307, 338, 432, 581, 283, 412, 443, 313, 626, 446, 426, 282, 387, 327, 350, 542, 439, 500, 321, 329, 303, 291, 620, 472, 476, 433, 493, 281, 480, 203, 442, 513, 454, 345, 304, 288, 341, 342, 430, 257, 409, 543, 366, 514, 556, 418, 197, 324, 308, 361, 217, 557, 98, 260, 33, 261, 179, 174, 548, 346, 214, 1, 3, 536, 143, 46, 429, 70, 21, 22, 7, 13, 191, 259, 343, 218, 83, 158, 156, 437, 467, 349, 374, 117, 104, 385, 369, 199, 57, 293, 518, 508, 43, 444, 5, 406, 546, 474, 498, 417, 407, 510, 284, 90, 414, 201, 130, 73, 469, 99, 100, 101, 107, 108, 449, 427, 488, 66, 115, 116, 192, 416, 144, 28, 11, 30, 68, 233, 27, 59, 298, 55, 419, 119, 34, 601, 344, 200, 118, 415, 436, 317, 515, 588, 506, 516, 234, 31, 88, 230, 318, 390, 223, 312, 319, 286, 471, 370, 482, 475, 102, 103, 176, 389, 14, 16, 109, 575, 477, 494, 167, 353, 9, 95, 294, 597, 598, 228, 466, 175, 97, 163, 316, 160, 492, 162, 290, 170, 164, 168, 285, 479, 136, 65, 478, 207, 81, 401, 378, 121, 540, 208, 289, 133, 295, 147, 82, 146, 161, 141, 165, 139, 140, 135, 134, 71, 63, 74, 39, 465, 552, 554, 463, 435, 413, 85, 172, 52, 35, 53, 216, 154, 339, 202, 483, 232, 333, 335, 171, 566, 568, 571, 453, 561, 560, 334, 331, 337, 330, 539, 569, 332, 459, 452, 75, 78, 531, 574, 602, 336, 579, 173, 496, 580, 86, 44, 512, 184, 299, 84, 428, 517 ****Serial Numbers Added 5/2/2025**** 533, 537, 538, 600, 615, 617, 618, 619, 642, 219, 348, 392, 393, 394; (2) OUS ONLY 1 ****Serial Numbers Added 5/2/2025**** 2, 3, 4, 8, 11, 16, 20, 28, 29, 30, 37, 57, 58; (3) OUS ONLY 90, 48, 50, 114, 62, 33, 21, 127, 36, 95, 87, 86, 79, 29, 140, 110, 32, 60, 76, 111, 9, 70, 55, 121, 75, 14, 66, 22, 146, 23, 44, 45, 58, 42, 137, 13, 122, 52, 61, 109, 41, 34, 103, 16, 132, 117, 17, 102, 72, 158, 99, 35, 160, 30, 31, 37, 135, 94, 57, 138, 10, 26, 59, 80, 63, 74, 27, 28, 54, 88, 24, 11, 20, 101, 89, 91, 157, 19, 12, 96, 64, 69 ****Serial Numbers Added 5/2/2025**** 15, 18, 25, 38, 39, 40, 43, 47, 65, 68, 71, 81, 84, 93, 98, 105, 108, 115, 118, 120, 124, 126, 136, 142, 144, 149, 151, 153, 159, 163, 168, 169, 173, 174, 176, 179, 180, 181, 182, 186, 187, 190, 191, 192, 193, 196, 197, 198, 207, 211, 213, 224, 225, 227, 231, 236, 242.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 16 of 20

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

Z-1157-2025
Recall number
Z-1157-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
602 units (94 US, 508 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262, 273, 270, 218, 235, 111, 146, 237, 43, 68, 210, 211, 212, 213, 34, 254, 168; (2) 259, 260, 55, 268, 147, 375, 404, 112, 376, 228, 229, 453, 53, 72, 71, 300, 157, 340, 28, 207, 216, 217, 68, 177, 291, 299, 29, 249, 227, 289, 354, 148, 205, 235, 41, 141, 262, 37, 298, 331, 104, 46, 111, 84, 208, 122, 110, 233, 175, 153, 206, 456, 393, 387, 189, 200, 218, 345, 346, 114, 173, 431, 149, 258, 184, 237, 385, 167, 14, 364, 4, 398, 30, 231, 103, 38, 178, 1, 321, 326, 313, 320, 180, 116, 107, 342, 350, 373, 372, 343, 348, 349, 351, 186, 195, 302, 301, 170, 171, 82, 210, 330, 307, 73, 93, 108, 143, 15, 62, 361, 119, 286, 89, 90, 77, 369, 161, 179, 131, 132, 20, 155, 191, 244, 245, 212, 323, 27, 106, 35, 150, 317, 88, 118, 100, 163, 337, 139, 165, 166, 137, 138, 247, 162, 9, 67, 94, 95, 40, 391, 91, 12, 11, 213, 272, 117, 21, 54, 74, 64, 192, 204, 85, 238, 341, 125, 190, 16, 363, 80, 311, 275, 44, 370, 334, 70, 303, 75, 353, 360, 36, 282, 57, 115, 224, 377, 10, 316, 198, 424, 335, 34, 236, 23, 325, 322, 154, 211, 332, 127, 355, 69, 60, 61, 279, 402, 329, 278, 63, 277, 432, 281, 98, 197, 151, 379, 76, 194, 222, 13, 59, 280, 371, 164, 359, 193, 430, 319, 32, 121, 86, 240, 58, 266, 18, 19, 92, 221, 105, 160, 39, 42, 120, 219, 187, 396, 446, 367, 242, 423, 257, 312, 327, 152, 447, 448, 47, 48, 52, 333, 324, 392, 365, 83, 96, 255, 256, 159, 234, 128, 134, 135, 226, 223, 386, 287, 309, 310, 414, 99, 413, 246, 8, 426, 420, 315, 293, 169, 123, 220, 79, 201, 196, 31, 384, 87, 283, 374, 421, 422, 267, 454, 439, 284, 395, 146, 427, 314, 450, 140, 241, 306, 133, 158, 230, 269, 145, 232, 109, 338, 362, 168, 368, 292, 56, 433, 296, 5, 124, 290, 43, 248, 276, 17, 243, 142, 144, 274, 7, 65, 66, 214 ****Serial Numbers Added 5/2/2025**** 400, 405, 434, 435, 251, 252, 253, 254, 366; (3) OUS ONLY 10, 6, 7, 5, 4, 14 ****Serial Numbers Added 5/2/2025**** 3, 8, 9, 13, 17, 18, 19, 20, 21, 23, 24, 25, 28, 33, 34, 35, 39, 41, 44, 45, 47, 49, 52, 53, 54, 56, 58, 65, 70, 72.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 17 of 20

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

Z-1158-2025
Recall number
Z-1158-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
1,314 units (270 US, 1044 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801; Serial Numbers: (1) 213, 407, 85, 89, 320, 73, 308, 288, 172, 295, 110, 406, 4444, 149, 350, 243, 143, 146, 109, 413, 137, 335, 270, 319, 95, 322, 324, 374, 170, 440, 184, 64, 373, 442, 431, 136, 279, 75, 251, 400, 271, 337, 329, 232, 261, 262, 477, 564, 354, 361, 443, 104, 114, 82, 490, 196, 370, 84, 107, 528, 247, 205, 42, 117, 469, 103, 520, 446, 78, 304, 153, 323, 457, 470, 472, 150, 277, 147, 547, 462, 479, 511, 285, 487, 101, 524, 282, 76, 510, 130, 356, 494, 178, 467, 505, 239, 225, 459, 265, 275, 485, 549, 534, 365, 314, 481, 77, 552, 44, 62, 158, 535, 453, 338, 399, 215, 37, 360, 36, 408, 420, 276, 68, 359, 584, 608, 563, 556, 557, 597, 601, 605, 553, 551, 516, 612, 614, 590, 540, 591, 617, 616, 599, 602, 570, 618, 574, 560, 609, 526, 559, 603, 600, 575, 593, 589, 624, 604, 372, 212, 475, 142, 97, 236, 237, 87, 53, 376, 111, 74, 394, 138, 185, 515, 162, 79, 35, 347, 134, 254, 416, 242, 219, 47, 250, 336, 299, 127, 145, 398, 471, 531, 290, 533, 198, 422, 380, 532, 168, 140, 483, 484, 228, 478, 460, 211, 468, 125, 102, 268, 269, 414, 543, 466, 105, 208, 106, 217, 263, 507, 202, 154, 273, 264, 175, 501, 144, 465, 315, 502, 188, 252, 379, 439, 298, 436, 278, 135, 391, 390, 200, 201, 224, 187, 404, 311, 498, 183, 296, 430, 139, 94, 156, 122, 197, 300, 98, 393, 132, 112, 63, 163, 45, 116, 189, 66, 90, 253, 274, 260, 368, 367, 191, 152, 331, 161, 67, 464, 503, 451, 226, 409, 155, 248, 61, 108, 297, 281, 128, 129, 318, 423, 518, 527, 506, 415, 521, 529, 417, 432, 292, 362, 246, 438, 497, 328, 450, 181, 173, 233, 289, 234, 326, 509, 519, 148, 568, 238, 583, 491, 536, 240, 69, 60, 283, 227, 396, 286, 349, 204, 230, 447, 334, 174, 49, 397, 83, 291, 448, 426, 427, 317, 571, 199, 500, 210, 192, 166, 293, 387, 258, 72, 118, 257, 133, 425, 206, 180, 327, 339, 179, 182, 306, 382, 160, 244, 115, 48, 93, 473, 537, 548, 550, 495, 369, 480, 577, 539, 303, 302, 207, 96, 280, 231, 364, 301, 454, 88, 325, 167, 445, 428, 316, 434, 435, 489, 555, 544, 562, 522, 313, 71, 346, 50, 141, 124, 508, 410 ****Serial Numbers Added 5/2/2025**** 444, 195; (2) 219, 469, 473, 464, 254, 845, 272, 912, 105, 323, 239, 144, 266, 891, 398, 319, 339, 182, 116, 559, 391, 534, 107, 680, 204, 675, 255, 153, 350, 442, 681, 690, 691, 260, 325, 688, 280, 180, 318, 702, 313, 468, 463, 761, 392, 400, 139, 158, 183, 78, 374, 427, 205, 482, 592, 593, 462, 121, 467, 220, 381, 19, 326, 100, 823, 213, 214, 215, 410, 508, 678, 545, 143, 724, 337, 360, 75, 1008, 181, 842, 555, 11, 244, 793, 189, 190, 380, 98, 343, 757, 955, 341, 1021, 208, 59, 361, 971, 114, 362, 129, 197, 174, 687, 281, 117, 554, 270, 918, 147, 113, 848, 756, 758, 108, 981, 379, 441, 446, 173, 271, 921, 495, 159, 778, 779, 383, 419, 472, 894, 689, 120, 122, 123, 124, 125, 126, 127, 332, 782, 876, 301, 262, 1002, 403, 67, 112, 175, 871, 294, 269, 704, 149, 194, 249, 432, 870, 142, 892, 321, 87, 790, 1, 261, 679, 141, 766, 514, 744, 798, 1023, 900, 901, 553, 747, 903, 670, 717, 907, 544, 886, 943, 745, 941, 527, 815, 799, 800, 963, 549, 663, 662, 669, 965, 697, 671, 674, 579, 603, 604, 830, 938, 939, 740, 888, 617, 979, 621, 1065, 902, 820, 887, 716, 665, 577, 748, 739, 672, 825, 736, 949, 860, 877, 751, 737, 813, 648, 632, 1061, 539, 228, 368, 950, 489, 622, 896, 27, 14, 749, 546, 552, 548, 367, 366, 289, 359, 131, 16, 423, 874, 243, 60, 176, 677, 880, 628, 637, 685, 491, 25, 345, 349, 6, 29, 625, 93, 457, 140, 63, 238, 299, 385, 166, 364, 84, 5, 506, 772, 320, 355, 557, 227, 305, 188, 827, 453, 650, 883, 171, 26, 889, 833, 282, 574, 956, 913, 585, 531, 905, 822, 477, 417, 754, 684, 509, 297, 342, 1009, 972, 83, 945, 743, 755, 924, 817, 791, 589, 726, 720, 399, 460, 503, 1014, 1015, 777, 831, 431, 481, 486, 274, 1041, 245, 298, 1049, 395, 230, 523, 686, 259, 520, 521, 522, 993, 708, 738, 878, 86, 890, 50, 664, 85, 768, 7, 333, 405, 287, 382, 433, 229, 568, 500, 34, 336, 106, 541, 56, 196, 236, 567, 659, 770, 694, 841, 308, 70, 537, 421, 570, 819, 30, 668, 241, 79, 92, 73, 353, 811, 722, 160, 80, 436, 529, 90, 302, 273, 74, 137, 454, 187, 402, 479, 42, 290, 866, 496, 588, 375, 587, 452, 210, 71, 524, 95, 269, 934, 69, 502, 581, 172, 32, 476, 288, 807, 77, 317, 606, 928, 847, 803, 560, 28, 33, 38, 192, 193, 35, 304, 804, 146, 857, 163, 115, 646, 660, 406, 908, 234, 312, 110, 340, 806, 91, 89, 44, 65, 578, 784, 450, 128, 904, 40, 801, 802, 525, 285, 653, 49, 852, 62, 556, 43, 161, 39, 856, 853, 851, 265, 206, 258, 656, 154, 356, 41, 155, 157, 863, 652, 855, 657, 499, 916, 583, 240, 165, 324, 1032, 933, 440, 237, 257, 425, 654, 709, 46, 162, 655, 358, 540, 156, 31, 279, 818, 68, 96, 658, 885, 286, 216, 456, 186, 357, 177, 619, 64, 998, 292, 828, 528, 558, 264, 404, 451, 838, 283, 284, 401, 530, 967, 478, 199, 152, 201, 202, 303, 666, 1006, 771, 580, 645, 995, 195, 599, 676, 595, 424, 586, 696, 409, 947, 605, 420, 449, 226, 752, 184, 978, 393, 198, 946, 627, 765, 647, 895, 413, 682, 789, 17, 422, 596, 741, 275, 235, 573, 251, 533, 727, 846, 1035, 225, 630, 164, 667, 733, 458, 742, 4, 439, 118, 217, 418, 203, 808, 263, 429, 148, 384, 809, 369, 82, 10, 330, 24, 598, 231, 224, 233, 88, 840, 407, 844, 649, 753, 673, 276, 438, 444, 119, 1026, 412, 715, 732, 411, 953, 958, 513, 725, 623, 731, 21, 992, 762, 882, 824, 826, 45, 505, 168, 542, 507, 66, 396, 497, 485, 490, 494, 643, 644, 543, 351, 636, 849, 633, 634, 504, 97, 550, 551, 484, 631, 316, 639, 640, 547, 448, 642, 563, 591, 52, 53, 22, 277, 278, 207, 835, 836, 773, 331, 982, 1000, 1013, 832, 501, 327, 775, 810, 698, 575, 576, 1046, 386, 764, 430, 1033, 795, 927, 1018, 997, 785, 861, 487, 584, 1050, 626, 363, 480, 498, 721, 919, 693, 712, 510, 898, 869, 984, 306, 561, 378, 221, 222, 829, 899, 232, 344, 61, 701, 415, 711, 18, 352, 47, 435, 307, 36, 641, 714, 1048, 515, 957, 178, 179, 250, 867, 872, 710, 974, 99, 247, 54, 692, 408, 906, 455, 132, 133, 416, 314 ****Serial Numbers Added 5/2/2025**** 969, 970, 973, 1007, 1017, 1052, 3; (3) 32, 20, 17, 26, 39, 46, 8, 34, 29, 10, 27, 41, 53, 49, 33, 23 ****Serial Numbers Added 5/2/2025**** 21, 22, 24, 25, 36, 40, 42, 54, 68, 116, 118, 194, 13, 30, 44, 52, 56, 59, 62, 63, 64, 66, 67, 69, 70, 73, 74, 75, 76, 80, 82, 83, 84, 85, 86, 88, 89, 90, 91, 92, 93, 94, 96, 98, 100, 102, 104, 105, 106, 108, 111, 112, 113, 114, 117, 122, 123, 124, 128, 130, 141, 144, 145, 146, 151, 152, 153, 154, 155, 157, 160, 162, 165, 168, 173, 189.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 18 of 20

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

Z-1159-2025
Recall number
Z-1159-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
1,837 units (337 US, 1500 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

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.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 19 of 20

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

Z-1160-2025
Recall number
Z-1160-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
4,221 units (1480 US, 2741 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722079, (2) 722224, (3) 722234; UDI-DI: (1) 00884838085268, (2) 00884838099258, (3) 00884838116771; Serial Numbers: (1) 942, 948, 702, 703455, 703457, 703465, 703904, 45, 1316, 709, 710, 711, 713, 60, 213, 1297, 1399, 1369, 703309, 1238, 703416, 1042, 715, 703368, 703562, 703335, 465, 674, 753, 730, 703497, 804, 703413, 1142, 1410, 703329, 1090, 439, 526, 1379, 899, 327, 637, 455, 653, 593, 1018, 898, 1040, 497, 900, 1164, 334, 1063, 792, 919, 1157, 595, 250, 1246, 703532, 737, 703409, 703419, 628, 703861, 1171, 599, 320, 429, 1393, 605, 895, 540, 998, 29, 1201, 704281, 361, 769, 938, 801, 1023, 668, 1283, 703332, 423, 671, 793, 480, 937, 1048, 1137, 1424, 580, 581, 1352, 1412, 460, 1387, 923, 981, 499, 703486, 64, 703383, 703510, 708, 703334, 496, 887, 903, 422, 758, 1267, 703558, 633, 999, 1041, 703324, 374, 459, 747, 1107, 703435, 528, 50, 246, 78, 703584, 520, 738, 703350, 351, 1189, 1401, 954, 436, 1103, 691, 992, 820, 32, 296, 267, 403, 48, 1411, 1370, 703395, 703420, 847, 879, 447, 448, 56, 1346, 445, 326, 703501, 428, 587, 216, 590, 703515, 1231, 251, 1402, 881, 318, 706, 703575, 611, 1290, 703391, 655, 1242, 275, 663, 588, 1007, 1365, 925, 854, 654, 703521, 896, 897, 1385, 1386, 488, 1247, 375, 836, 891, 940, 297, 298, 299, 268, 689, 717, 927, 928, 52, 703396, 1271, 396, 860, 1245, 862, 790, 840, 818, 1235, 774, 1436, 703344, 736, 1021, 574, 842, 884, 991, 613, 843, 885, 629, 802, 865, 703317, 1032, 1117, 1049, 1355, 1414, 703387, 703404, 703540, 598, 883, 910, 1204, 955, 703508, 1250, 1012, 1170, 58, 810, 777, 402, 703390, 1289, 1322, 413, 414, 415, 703327, 703333, 584, 721, 634, 617, 53, 57, 1013, 1084, 841, 1282, 703310, 1100, 945, 703314, 1310, 241, 46, 54, 703408, 908, 1430, 55, 1395, 703493, 1251, 1096, 1097, 227, 437, 438, 33, 946, 658, 795, 673, 856, 922, 776, 1064, 703495, 915, 1062, 631, 607, 1431, 18, 479, 314, 890, 867, 868, 909, 931, 645, 646, 325, 262, 1423, 703307, 1252, 412, 703418, 1311, 62, 70, 222, 247, 474, 742, 1187, 401, 703450, 407, 408, 481, 355, 356, 358, 359, 703, 800, 754, 703528, 1102, 703478, 41, 904, 608, 703311, 805, 930, 1108, 1363, 1358, 1359, 1360, 746, 424, 809, 848, 1258, 1006, 1098, 602, 703308, 989, 813, 703425, 957, 878, 703345, 1276, 755, 703323, 1309, 1312, 837, 229, 468, 469, 472, 888, 1059, 1381, 1382, 1156, 703559, 342, 343, 344, 345, 858, 859, 255, 1274, 1226, 1232, 1236, 1237, 911, 393, 394, 1219, 863, 1400, 585, 212, 959, 471, 1432, 987, 1391, 703389, 1043, 905, 427, 618, 594, 828, 1323, 731, 577, 573, 714, 228, 1222, 30, 366, 543, 921, 1200, 353, 751, 703379, 703402, 263, 350, 974, 239, 669, 703775, 387, 417, 766, 817, 1212, 1378, 1408, 1211, 1213, 1285, 1216, 68, 416, 703305, 290, 1380, 1033, 741, 1179, 703360, 572, 272, 1078, 453, 703306, 266, 534, 535, 536, 1010, 1054, 1270, 525, 65, 1022, 1163, 274, 1268, 1155, 703356, 703380, 703381, 750, 814, 1000, 1017, 1016, 333, 284, 1415, 703550, 703685, 1039, 1374, 330, 331, 332, 265, 679, 703388, 703551, 644, 783, 845, 846, 703826, 1077, 37, 293, 74, 965, 312, 341, 1306, 1205, 1206, 346, 66, 233, 703384, 703392, 759, 703806, 302, 557, 337, 703612, 550, 703592, 703597, 703611, 703866, 656, 1129, 75, 752, 1143, 316, 740, 703506, 971, 1288, 322, 967, 703653, 803, 1388, 961, 67, 1133, 319, 76, 524, 295, 388, 1004, 383, 1199, 1341, 703362, 949, 735, 675, 1182, 703479, 1299, 703369, 214, 703565, 760, 966, 1082, 632, 1120, 773, 704095, 704002, 704206, 703676, 703800, 704092, 703726, 703854, 703675, 704119, 704148, 704259, 703950, 704240, 704242, 704189, 704010, 703979, 704014, 703837, 704117, 703978, 703628, 703591, 704017, 703951, 1376, 703720, 703892, 703836, 703703, 704166, 704044, 703977, 704114, 704157, 704295, 704289, 1228, 703786, 703809, 704077, 704059, 703954, 704093, 703709, 703719, 704209, 703605, 704271, 704023, 704098, 703827, 703830, 703730, 703552, 704219, 1263, 703891, 703894, 703895, 703645, 704075, 704301, 704060, 704102, 703601, 703678, 704221, 1332, 704091, 703477, 703586, 703779, 703681, 703585, 703673, 704204, 704188, 703898, 703813, 704304, 704202, 703881, 704126, 703651, 703842, 703778, 703742, 704039, 704216, 703652, 704012, 703733, 703735, 703857, 703858, 703859, 703860, 703863, 703948, 703625, 703647, 704144, 704177, 704036, 704113, 703659, 703972, 703544, 703887, 704041, 703900, 704082, 703947, 703843, 703802, 703812, 704128, 703633, 703849, 703571, 703956, 704084, 704051, 703695, 703957, 704145, 703696, 703969, 703805, 704263, 703949, 704261, 704034, 703878, 704187, 704264, 704103, 704247, 703803, 704035, 703700, 703939, 703780, 703648, 703596, 703825, 703641, 703680, 704085, 703701, 703989, 704016, 704147, 703923, 703717, 703542, 703548, 703507, 704115, 703974, 703818, 704207, 703711, 703876, 703934, 704178, 704116, 704038, 704024, 703789, 703846, 704275, 703890, 704201, 703920, 703925, 704180, 703761, 703707, 704057, 704237, 703710, 1224, 1225, 704070, 704088, 703945, 703670, 703982, 703724, 703990, 704127, 704008, 703924, 703539, 703751, 703731, 703734, 703639, 704096, 703727, 704269, 703664, 703660, 704018, 703555, 703921, 704019, 703576, 703691, 703692, 704007, 704149, 704246, 704213, 703883, 704089, 703708, 704090, 704112, 703975, 704139, 703471, 703556, 704067, 703840, 703781, 703630, 704046, 704122, 703796, 703908, 703909, 703992, 704056, 704280, 704138, 704104, 703589, 703794, 1318, 703536, 703899, 704181, 703998, 704025, 703953, 704195, 704296, 704151, 704033, 704131, 704040, 704135, 703674, 704250, 703715, 704111, 703679, 704186, 704200, 703771, 704161, 703725, 704109, 703697, 704153, 704031, 703688, 704173, 703831, 703985, 703757, 703646, 703851, 704022, 703817, 704132, 704110, 703926, 703917, 703684, 703797, 704154, 703573, 704134, 704133, 703663, 703970, 703967, 703871, 704063, 703983, 703940, 703627, 704167, 704168, 703667, 703668, 703541, 703906, 703777, 704054, 704252, 703874, 703741, 704081, 703873, 703993, 703913, 703875, 704152, 703884, 704050, 704120, 703593, 703828, 703798, 704009, 703629, 703941, 704015, 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3429, 1413, 2060, 2059, 2612, 1568, 1696, 2118, 3109, 1441, 3114, 1164, 2024, 1732, 2110, 1144, 2634, 2496, 1704, 2200, 1131, 2073, 1695, 1761, 1948, 2207, 1818, 2249, 2760, 1945, 1977, 1289, 2371, 2372, 2942, 2560, 2065, 2067, 1617, 1127, 2092, 2513, 2048, 1746, 2992, 1419, 2471, 1751, 1502, 1152, 2115, 1513, 2136, 2173, 1599, 1823, 1683, 2095, 1996, 1539, 3124, 519, 368, 2836, 2415, 383, 563, 463, 675, 1040, 1205, 1676, 63, 1670, 1686, 2089, 1367, 1401, 988, 3386, 3387, 2574, 2163, 2724, 2725, 93, 1671, 1594, 1595, 2568, 2851, 2792, 2525, 932, 1427, 2322, 3441, 1092, 2605, 691, 2598, 3216, 3334, 3367, 1002, 985, 1792, 842, 1306, 2186, 2964, 1273, 943, 987, 3177, 1217, 1218, 1219, 1222, 1226, 1035, 1085, 505, 2423, 341, 359, 87, 1007, 3163, 9, 935, 201, 916, 2853, 578, 66, 67, 223, 1162, 737, 1275, 3072, 2044, 2628, 2711, 1786, 744, 1206, 1154, 1780, 1452, 1475, 757, 23, 915, 2276, 534, 783, 65, 802, 2789, 1774, 14, 86, 2841, 531, 3280, 2837, 1163, 181, 3129, 3036, 2661, 3008, 2644, 30, 634, 2164, 1406, 2710, 3223, 19, 2230, 2480, 3135, 1962, 2218, 227, 337, 822, 175, 1981, 1953, 1864, 371, 653, 749, 1952, 382, 1023, 4, 883, 2885, 3065, 2345, 2482, 31, 1523, 59, 898, 614, 866, 2730, 29, 52, 774, 597, 853, 810, 1722, 2886, 1876, 2777, 3225, 2890, 171, 2310, 2713, 717, 978, 1852, 1861, 3196, 2142, 2232, 2712, 2493, 2167, 237, 1181, 2927, 3261, 2251, 672, 2430, 3457, 361, 367, 1764, 655, 2561, 1660, 3320, 2237, 734, 1105, 270, 3006, 1048, 340, 3222, 1183, 2015, 1557, 2589, 977, 1030, 2481, 2804, 1795, 1623, 416, 623, 780, 3030, 1690, 2475, 1801, 1772, 1180, 906, 791, 2250, 2271, 1304, 1179, 1863, 1072, 264, 394, 2450, 821, 2780, 638, 2477, 990, 2646, 2674, 2361, 2658, 2781, 2191, 410, 2446, 2487, 412, 2444, 459, 504, 2362, 1076, 1714, 2535, 2285, 2445, 1681, 1713, 2360, 2264, 2779, 2643, 1715, 2570, 2286, 1498, 2478, 2485, 2447, 1688, 2797, 2719, 1075, 460, 533, 532, 596, 868, 2698, 200, 880, 1424, 1737, 801, 1326, 1330, 1350, 1369, 1609, 2244, 2245, 2373, 3099, 3264, 535, 536, 1951, 936, 925, 934, 919, 920, 929, 930, 2400, 1878, 570, 918, 3195, 848, 3160, 3284, 921, 74, 2401, 1685, 51, 92, 576, 2526, 928, 3382, 1763, 1767, 3349, 2531, 2604, 2022, 2960, 1066, 2537, 1579, 913, 923, 3136, 1248, 2034, 1817, 126, 972, 3122, 457, 1928, 711, 1031, 2399, 117, 2944, 864, 241, 2397, 1232, 911, 510, 1735, 1592, 924, 498, 927, 931, 198, 3217, 168, 794, 137, 2896, 1400, 677, 118, 143, 473, 384, 61, 731, 889, 1515, 568, 718, 769, 2558, 487, 2991, 2626, 392, 1505, 914, 1211, 2832, 2315, 646, 1496, 2642, 1723, 721, 1065, 910, 142, 562, 692, 538, 2413, 2075, 170, 2657, 1471, 2068, 1157, 397, 96, 3239, 1187, 1646, 557, 1134, 2521, 1582, 3242, 676, 1188, 2591, 2933, 405, 2849, 1581, 877, 2950, 716, 3183, 497, 1005, 496, 3230, 378, 1804, 1779, 407, 2320, 1044, 2953, 1707, 1104, 3236, 878, 2431, 3372, 2538, 1067, 1129, 1194, 1114, 2429, 2555, 1137, 1765, 489, 758, 1280, 1281, 2864, 2923, 3311, 2565, 1017, 1809, 2678, 3440, 1785, 3412, 1446, 2272, 3293, 548, 1313, 2479, 2190, 2134, 2343, 2424, 2947, 2704, 2260, 3113, 2707, 2745, 2715, 3212, 2101, 2102, 2105, 1815, 1814, 2618, 2103, 2813, 2905, 2788, 3009, 2819, 2817, 2749, 1800, 1799, 2261, 2706, 2714, 2267, 3021, 2818, 2889, 2812, 2758, 2828, 2404, 3250, 3287, 2263, 2299, 2751, 2705, 2259, 3426, 1930, 2300, 1449, 2509, 2588, 3347, 375, 1139, 2844, 156, 3221, 1562, 803, 671, 1538, 236, 1730, 2126, 16, 13, 399, 1794, 2151, 2007, 3, 1331, 7, 2078, 8, 2946, 687, 2999, 1182, 358, 3259, 3237, 756, 2915, 1504, 508, 393, 768, 1506, 2026, 706, 708, 499, 530, 1148, 660, 2273, 658, 1050, 1051, 1052, 1348, 2277, 3383, 2742, 3191, 1339, 2709, 838, 348, 903, 1088, 1155, 2159, 2547, 2566, 872, 1647, 293, 3285, 808, 3456, 32, 2625, 2539, 3379, 1153, 1984, 2700, 855, 3418, 2863, 795, 243, 664, 2665, 1736, 3271, 542, 97, 610, 48, 122, 203, 604, 729, 2344, 1728, 3445, 1428, 1242, 2440, 698, 760, 688, 2909, 689, 1207, 1021, 1068, 1022, 697, 2119, 1465, 700, 2342, 1087, 703, 704, 1176, 743, 759, 699, 1227, 2209, 2348, 751, 2100, 1407, 705, 1373, 1480, 992, 2389, 2517, 701, 3396, 448, 449, 3061, 1034, 1173, 1826, 1991, 3204, 635, 528, 529, 2848, 2592, 3227, 720, 1709, 1272, 2402, 800, 68, 1016, 85, 3234, 558, 882, 193, 2050, 605, 311, 2160, 926, 779, 1566, 1588, 1656, 629, 631, 1649, 1593, 256, 1447, 2046, 1602, 2013, 18, 1536, 1580, 1387, 1433, 2021, 1957, 1678, 1734, 1758, 111, 2011, 2076, 2099, 423, 1703, 1933, 2287, 752, 3167, 1837, 2275, 1196, 1391, 1393, 1402, 1404, 2916, 1645, 1359, 1443, 1587, 456, 98, 1286, 620, 1392, 1399, 1422, 38, 1677, 1691, 127, 1710, 2009, 1345, 2871, 2014, 1600, 2028, 1425, 1340, 1333, 1855, 2153, 1585, 2339, 209, 1372, 1408, 1432, 302, 1868, 2049, 305, 1586, 310, 1583, 2055, 1429, 133, 1535, 1537, 1543, 1544, 1263, 1342, 1865, 1597, 1398, 2193, 249, 1462, 1596, 1603, 1598, 1327, 2056, 2175, 1936, 1968, 2330, 1351, 1699, 2016, 386, 1343, 1980, 891, 1495, 2002, 2087, 2305, 1584, 1666, 506, 259, 81, 2069, 303, 304, 11, 2398, 55, 58, 1806, 1969, 1601, 1621, 2693, 248, 1835, 1805, 1644, 77, 2104, 2252, 501, 2892, 2451, 2608, 2615, 1071, 1133, 976, 1762, 24, 2396, 2098, 727, 2809, 1932, 2621, 1867, 773, 2850, 1008, 334, 1338, 941, 942, 149, 429, 1976, 1978, 890, 2541, 776, 551, 1365, 1366, 2157, 57, 725, 1434, 292, 3150, 2086, 294, 344, 186, 2137, 146, 152, 550, 2651, 349, 2323, 3193, 1963, 1590, 2017, 162, 601, 3127, 2441, 299, 1043, 602, 829, 70, 71, 167, 1871, 2366, 1522, 984, 389, 390, 546, 828, 3292 ****Serial Numbers Added 5/2/2025**** 3023, 3026, 3044, 3045, 3049, 3052, 3053, 3078, 3085, 3087, 3106, 3107, 3157, 3158, 3164, 3165, 3172, 3178, 3179, 3273, 3282, 3291, 3296, 3305, 3314, 3328, 3333, 3336, 3345, 3352, 3354, 3362, 3373, 3374, 3376, 3384, 3393, 3401, 3414, 3419, 3448, 3450, 3454, 3483, 3486, 3489, 3490, 3503, 3509, 3510, 3514, 3515, 3516, 3525, 3526, 3527, 3539, 3541, 3564, 3577, 3579, 3582, 3642; (3) 43, 21, 13, 41, 19, 20, 29, 16, 27, 38, 30, 53, 17, 66 ****Serial Numbers Added 5/2/2025**** 55, 59, 60, 68, 70, 71, 76, 79, 85, 87, 92, 94, 97, 98, 99, 101, 102, 107, 108, 119, 123, 124, 133, 140, 155, 159, 163, 165, 168, 171, 174, 175, 178, 191, 198, 208, 209, 212, 217, 222, 223, 225, 233, 248, 253, 257, 262, 300, 320, 340, 358, 12, 18, 23, 26, 31, 32, 36, 37, 39, 40, 42, 44, 45, 46, 47, 49, 51, 52, 56, 57, 58, 64, 78, 82, 83, 90, 91, 93, 95, 103, 106, 114, 115, 120, 127, 131, 132, 134, 135, 137, 138, 143, 145, 148, 149, 156, 158, 177, 179, 180, 189, 190, 192, 197, 224, 229, 235, 237, 239, 241, 243, 247, 249, 254, 275, 296, 304, 305, 328, 378, 387, 388; (4) OUS ONLY 50, 38, 7, 39, 40, 8, 30, 23, 27, 15, 26, 18, 28, 21, 36, 10, 11, 13, 14, 20, 42, 9, 31 ****Serial Numbers Added 5/2/2025**** 24, 25, 32, 34, 41, 43, 44, 45, 46, 54, 55, 56, 57, 73, 82.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

device · product 20 of 20

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

Z-1161-2025
Recall number
Z-1161-2025
Initiated
January 13, 2025
Classification
Class I
Status
Ongoing
Quantity
80 units (OUS ONLY)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possibility of the patient falling from the table related to the mattress used on the patient table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Code information

Catalog numbers: (1) 722400; UDI-DI: No UDI; Serial Numbers: 531, 314, 432, 376, 496, 315, 491, 361, 389, 486, 427, 547, 330, 444, 441, 536, 479, 555, 443, 329, 440, 363, 445, 344, 286, 508, 446, 511, 135, 291, 221, 31, 143, 79, 69, 2, 160, 381, 157, 386, 174, 269, 206, 240, 151, 348, 283, 308, 188, 370, 477, 360, 319, 482, 317, 6, 199, 217, 218, 76, 364, 382, 233, 16, 258, 271, 393, 407, 184, 303, 338, 414, 321, 89, 413, 429, 502, 506, 507, 33.

Distribution pattern

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.