PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

Recall number

Z-0676-2025

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

Status

Open, Classified

Initiated

2024-11-11

Posted

2024-12-12

Terminated

not on file

Reason

Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

Root cause

Equipment maintenance

Action

Philips Medical Systems notified consignees on 11/11/2024 via letter. Consignees were instructed that affected systems may continue to be used in accordance with their Indications for Use and Instructions for Use (IFU), to keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, circulate this notice to all users of the system so that they are aware of the issue, and if you experience erratic movement of the C-arm and/or if you see a portion of black area on the X-ray image, please call your local Philips representative to report the event. Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit. Consignees were also instructed to notify customers if further distributed and inform Philips about the transfer through the email account: IGT_Recalls@philips.com. Philips requested consignees complete and return the provided response form. On 11/24/2025, Philips sent a follow up letter to consignees to provide an update to the Urgent Medical Device Correction (MDC) issued on 11/11/2024. The updated letter informed consignees that after further technical investigation on both the hydrogen embrittlement and fatigue conditions, Philips has confirmed that these failure mechanisms do not apply to the bolts in question. Therefore, replacement is not required, even after 10 years of use. As a result, the risks and actions outlined in the original MDC no longer apply to affected systems.

Quantity

2,782 units

Distribution

Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen.

Lot, serial or model codes

1. Model Number: 722010. UDI (Serial Numbers): (01)00884838054189(21)164 (164); (01)00884838059030(21)272 (272); (01)00884838059030(21)819 (819); (01)00884838059030(21)828 (828); No UDI (33, 39, 42, 43, 65, 67, 69, 79, 107, 119, 127, 158, 160, 169, 177, 190, 191, 209, 213, 214, 215, 218, 227, 229, 239, 240, 241, 252, 274, 280, 285, 286, 290, 296, 298, 306, 308, 316, 342, 343, 344, 360, 364, 365, 395, 411, 414, 422, 423, 453, 468, 477, 478, 480, 485, 488, 499, 500, 505, 521, 527, 531, 567, 572, 585, 592, 604, 605, 611, 624, 636, 637, 638, 641, 646, 648, 651, 656, 662, 668, 670, 671, 673, 677, 679, 683, 690, 694, 698, 714, 728, 730, 755, 763, 764, 780, 785, 787, 788, 791, 792, 794, 809, 818, 830, 833, 838, 839, 873, 878, 882, 890, 896, 902, 905, 914, 917, 920, 921, 931, 932, 937, 939, 946, 968, 970, 979, 986, 987, 992, 999, 1005, 1009, 1011, 1025, 1028, 1040, 1041, 1042, 1043, 1048, 1064, 1069, 1078, 1082, 1084, 1109, 1112, 1118, 1123, 1126, 1128, 1132, 1144, 1170, 1173, 1176, 1181, 1183, 1209, 1210, 1214, 1230, 1233, 1234, 1235, 1236, 1261, 1263, 1275, 1279, 1283, 1292, 1297, 1442, 601, 654, 1122, 1198, 332, 777, 666, 301, 608, 1081, 426, 924, 577, 265, 1047, 1187, 219, 959, 901, 552, 888, 1140, 64, 935, 1008, 1213, 1015, 1016, 1017, 1018, 374, 524, 1153, 1192, 1194, 841, 964, 996, 233, 1211, 721, 1190, 1188, 806, 907, 50, 418, 71, 400, 1168, 1116, 1093, 53, 370, 596, 45, 712, 1148, 323, 825, 402, 713, 195, 176, 508, 123, 1197, 91, 602, 245, 535, 230, 231, 232, 991, 248, 92, 187, 502, 1124, 537, 1199, 941, 553, 302, 289, 173, 134, 1137, 948, 509, 619, 1034, 447, 707, 708, 1285, 928, 1113, 802, 803, 192, 613, 614, 393, 506, 369, 1206, 264, 699, 759, 722, 1100, 350, 748, 1220, 657, 658, 659, 854, 565, 734, 735, 736, 737, 228, 642, 1054, 490, 391, 425, 513, 898, 424, 105, 993, 732, 580, 1256, 704, 695, 696, 238, 706, 1253, 1327, 1032, 319, 1252, 469, 541, 731, 1019, 1023, 1215, 247, 1191, 856, 51, 971, 603, 1003, 270, 267, 268, 1242, 47, 1089, 831, 530, 1091, 193, 578, 322, 1161, 126, 197, 884, 146, 62, 1095, 273, 29, 63, 412, 346, 622, 371, 740, 715, 635, 1134, 1135, 520, 936, 990, 1002, 911, 49, 978, 586, 1004, 1036, 653, 1086, 1180, 776, 288, 1245, 72, 625, 1221, 1087, 984, 253, 398, 1125, 1269, 773, 80, 380, 224, 222, 1010, 957, 282, 847, 1151, 1083, 1268, 711, 685, 686, 1104, 663, 664, 863, 799, 1224, 1225, 771, 631, 494, 1250, 652, 1106, 383, 52, 1278, 861, 906, 872, 382, 409, 969, 139, 1202, 28, 410, 1050, 915, 544, 299, 769, 540, 1007, 1305, 1306, 612, 1203, 1216, 620, 300, 1058, 600, 384, 90, 811, 1138, 967, 795, 1154, 655, 610, 895, 136, 944, 255, 415, 866, 954, 720, 83, 1141, 86, 88, 246, 801, 498, 1039, 574, 495, 1265, 1177, 1178, 128, 1105, 1266, 97, 703, 526, 1237, 650, 98, 427, 496, 1286, 897, 649, 401, 963, 876, 275, 800, 1012, 102, 1238, 475, 1090, 261, 739, 356, 877, 34, 35, 249, 1196, 1276, 1294, 927, 375, 162, 333, 943, 293, 903, 1111, 797, 416, 955, 1145, 514, 100, 1273, 1157, 860, 942, 961, 287, 1021, 1033, 998, 733, 154, 353, 1150, 832, 474, 471, 962, 1037, 1053, 579, 211, 404, 428, 503, 493, 1120, 837, 406, 351, 528, 559, 217, 529, 58, 566, 588, 589, 590, 591, 593, 594, 891, 949, 1146, 1267, 518, 568, 842, 744, 106, 103, 104, 385, 956, 70, 850, 250, 1097, 904, 75, 199, 328, 182, 294, 77, 751, 810, 1280, 1300, 1077, 858, 362, 1207, 874, 131, 1218, 1130, 972, 710, 934, 587, 645, 855, 178, 790, 466, 94, 276, 952, 548, 115, 997, 116, 753, 606, 320, 114, 181, 1182, 1065, 562, 180, 789, 1067, 1129, 975, 626, 89, 523, 243, 223, 1617, 186, 555, 598, 1119, 702, 321, 338, 137, 1051, 660, 1088, 741, 742, 1029, 1136, 95, 844, 973, 1162, 1000, 394, 142, 561, 277, 269, 304, 558, 132, 804, 1044, 822, 852, 476, 862, 96, 396, 254, 373, 875, 312, 313, 900, 220, 563, 330, 367, 473, 515, 909, 112, 121, 762, 564, 1074, 1075, 20, 124, 357, 807, 834, 1066, 184, 697, 857, 634, 980, 782, 783, 125, 1096, 225, 812, 813, 1055, 913, 1185, 368, 349, 570, 781, 354, 386, 387, 525, 66, 388, 235, 236, 549, 251, 278, 868, 1006, 1060, 516, 517, 774, 60, 166, 501, 845, 846, 597, 381, 492, 908, 607, 507, 923, 775, 403, 719, 687, 78, 1030, 1031, 185, 1147, 689). 2. Model Number: 722011. No UDI. Serial Numbers: 157, 83, 308, 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, 87, 237, 255, 50, 171, 168, 22, 275, 344, 324, 140, 163, 172, 103, 82, 154, 215, 40, 69, 272, 286, 81, 224, 184, 266, 175, 146, 164, 334, 338, 165, 80, 231, 323, 327, 179, 145, 117, 6, 355, 151, 202, 21, 203, 214, 340, 18, 301, 302, 303, 304, 305, 306, 307, 257, 265, 127, 180, 259, 181, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 253, 230, 317, 198, 321, 204, 94, 104, 52, 290, 291, 244, 333, 287, 39, 282, 78, 216, 158, 329, 246, 295, 56, 337, 292, 125, 225, 300, 88, 309, 86, 222, 71, 156, 233, 31, 188, 77, 99, 238, 223, 51, 153, 68, 129, 186, 118, 119, 41, 55, 263, 278, 258, 32, 89, 108, 310, 311, 139, 141, 66, 274, 296, 243, 191, 227, 273, 161, 220, 242, 166, 189, 185, 100, 190, 299, 280, 199, 194, 74, 75, 228, 250, 251, 91, 213, 12, 212, 113, 152, 112, 111, 115, 114, 116, 43, 277, 313, 26, 27, 29. 3. Model Number: 722012. UDI (Serial Numbers): (01)00884838059054(21)1356 (1356); (01)00884838059054(21)191 (191); (01)00884838059054(21)351 (351); (01)00884838059054(21)583 (583); (01)00884838059054(21)655 (655); (01)00884838059054(21)796 (796); (01)00884838059054(21)950 (950); No UDI (1117, 1001, 1673, 1712, 585, 517, 1545, 70, 1715, 504, 757, 935, 1250, 1613, 2006, 1733, 1734, 2201, 1922, 741, 92, 1034, 1359, 1848, 865, 1908, 1166, 1113, 1659, 494, 335, 1804, 1473, 1408, 1401, 1588, 576, 595, 590, 2302, 1279, 2151, 481, 348, 543, 893, 1187, 1455, 2085, 2202, 423, 525, 1798, 1656, 399, 990, 1871, 951, 1652, 894, 1590, 1597, 596, 1054, 1189, 1099, 823, 1037, 566, 72, 448, 1606, 924, 1610, 686, 1108, 1294, 568, 500, 459, 469, 1422, 1077, 1537, 1035, 285, 243, 84, 1317, 1649, 1895, 1900, 1723, 878, 919, 1581, 2221, 2222, 1515, 1803, 1731, 1017, 1020, 380, 1811, 2171, 1497, 782, 418, 1053, 1558, 1336, 601, 1014, 684, 1265, 331, 389, 732, 751, 1324, 2276, 2086, 1285, 2219, 298, 814, 815, 1120, 278, 297, 1713, 1506, 580, 1098, 1852, 1307, 1858, 377, 758, 1598, 172, 2054, 856, 1690, 1407, 480, 690, 579, 1327, 733, 1091, 1254, 797, 213, 735, 1280, 2138, 828, 458, 1118, 740, 1249, 542, 1033, 2265, 490, 1075, 2203, 1321, 1396, 605, 606, 444, 66, 2092, 1269, 67, 244, 1002, 1022, 1023, 2264, 2234, 1805, 1192, 1823, 483, 484, 615, 2150, 892, 1478, 1262, 1688, 1961, 1732, 1062, 649, 650, 767, 1104, 1641, 1277, 1975, 276, 316, 1335, 1461, 159, 489, 766, 639, 669, 671, 1583, 451, 625, 651, 1047, 107, 1447, 99, 670, 124, 1616, 1660, 1083, 1807, 1924, 511, 1714, 122, 101, 75, 1406, 352, 492, 472, 1105, 642, 643, 1270, 577, 578, 1306, 855, 1456, 2269, 71, 1078, 2285, 1793, 1797, 1216, 948, 387, 498, 1662, 104, 1868, 1743, 369, 1239, 1561, 464, 2293, 1960, 616, 1508, 1084, 1038, 1058, 318, 1990, 1796, 1026, 1337, 685, 656, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 1586, 1617, 1904, 1354, 1918, 1906, 160, 383, 560, 68, 114, 1948, 1195, 518, 888, 1329, 1992, 323, 379, 792, 1003, 1219, 89, 115, 2003, 2004, 135, 1832, 2133, 2166, 562, 1941, 760, 859, 1593, 1608, 1947, 1950, 731, 520, 1328, 848, 2292, 1946, 274, 1063, 611, 1587, 1226, 613, 1271, 1842, 205, 2147, 1799, 1665, 187, 1513, 2015, 2207, 319, 2161, 1116, 1993, 208, 943, 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, 1293, 513, 1446, 1625, 1675, 1683, 1148, 1181, 207, 1305, 790, 499, 1716, 934, 1726, 85, 476, 1657, 1045, 1531, 1630, 851, 1827, 277, 1923, 1516, 404, 453, 321, 334, 197, 1869, 2215, 574, 1611, 1559, 2924, 1686, 1635, 858, 1224, 1345, 86, 2057, 1430, 1255, 1599, 302, 610, 1209, 920, 666, 1989, 2014, 2022, 1126, 1943, 1188, 1073, 1404, 1664, 103, 1272, 2063, 1467, 1596, 326, 926, 675, 756, 1027, 424, 1894, 2145, 2146, 2148, 2065, 1527, 1477, 2227, 1177, 1645, 93, 95.1167, 1595, 88, 1672, 909, 1210, 1512, 1101, 787, 1399, 123, 126, 136, 952, 953, 954, 1005, 1661, 2156, 320, 186, 455, 570, 1622, 1115, 1316, 1212, 975, 976, 1032, 1746, 986, 971, 1594, 233, 239, 640, 446, 69, 430, 1542, 76, 1607, 1211, 1004, 2046, 974, 1044, 505, 310, 192, 314, 852, 224, 1016, 1097, 315, 1532, 1964, 2135, 1357, 589, 1092, 248, 846, 963, 964, 1658, 1344, 1902, 328, 781, 1909, 1132, 1361, 1504, 1433, 229, 142, 962, 1260, 1094, 837, 333, 1681, 1815, 922, 1333, 774, 1492, 2047, 1655, 1855, 2098, 930, 1052, 1421, 627, 1428, 1994, 1802, 1956, 931, 1817, 309, 2168, 1168, 1562, 967, 167, 910, 632, 863, 957, 289, 137, 1040, 1444, 409, 993, 995, 57, 1072, 516, 2042, 1332, 809, 795, 1460, 170, 914, 1156, 347, 1291, 1971, 664, 180, 1376, 2107, 139, 350, 628, 1865, 550, 1872, 759, 1464, 1363, 1457, 2020, 553, 288, 1980, 1580, 1708, 1495, 1244, 556, 546, 806, 1289, 1284, 1144, 1145, 223, 1081, 1436, 726, 755, 648, 1391, 1972, 215, 871, 629, 1631, 125, 432, 966, 1157, 1623, 1702, 916, 2112, 2123, 2118, 98, 1297, 2103, 211, 1147, 1303, 2300, 2120, 199, 1833, 1874, 631, 1887, 891, 1382, 1471, 1818, 2270, 1878, 1462, 1384, 798, 165, 210, 1203, 1966, 1178, 1999, 793, 794, 667, 2196, 1669, 502, 1021, 1142, 1879, 1703, 2031, 659, 1572, 1076, 2291, 1093, 479, 1043, 1626, 2056, 608, 1624, 216, 2204, 1138, 839, 805, 381, 752, 555, 1548, 1814, 1808, 979, 390, 261, 269, 2188, 1056, 866, 1699, 619, 1267, 311, 477, 1174, 1485, 59, 541, 1415, 764, 388, 876, 1150, 1701, 1693, 2080, 1986, 772, 1241, 1819, 1898, 911, 978, 2093, 116, 56, 2181, 599, 2034, 1071, 622, 941, 1088, 1927, 1412, 181, 548, 582, 588, 1567, 1367, 1143, 1423, 1268, 279, 1592, 1122, 2028, 1375, 1059, 400, 166, 746, 771, 770, 2177, 280, 1202, 753, 2274, 2198, 1028, 581, 1309, 810, 1086, 524, 1390, 1721, 374, 738, 360, 992, 219, 1825, 1839, 652, 2102, 2127, 1834, 829, 1434, 665, 742, 737, 1360, 1349, 391, 415, 2095, 730, 1967, 1996, 763, 332, 867, 902, 917, 1366, 2096, 1201, 587, 1061, 2072, 1691, 1861, 407, 1741, 833, 554, 214, 779, 799, 2101, 1228, 2117, 534, 1348, 813, 1740, 1530, 998, 1266, 680, 1997, 441, 60, 803, 2195, 895, 509, 1736, 355, 1381, 112, 478, 227, 785, 291, 185, 1450, 540, 1976, 2016, 1591, 443, 106, 127, 382, 661, 727, 1137, 1795, 1128, 1377, 392, 1134, 1130, 296, 266, 1074, 376, 2067, 152, 1978, 663, 1678, 569, 1481, 2349, 436, 1929, 1654, 287, 944, 2176, 1413, 188, 2140, 1998, 635, 1089, 1668, 1256, 2272, 660, 1671, 743, 58, 128, 1287, 1079, 61, 982, 693, 1388, 184, 1479, 1801, 2074, 1342, 405, 1535, 1882, 1127, 980, 2058, 1705, 260, 539, 2278, 748, 1435, 528, 506, 1885, 1926, 2073, 572, 688, 903, 410, 901, 869, 728, 91, 218, 419, 275, 830, 2094, 1411, 1222, 1397, 272, 2153, 1711, 1965, 1480, 1937, 1298, 414, 338, 1237, 1151, 1152, 1347, 1977, 1836, 1131, 1242, 573, 1484, 117, 2082, 1695, 817, 1536, 630, 593, 773, 1214, 936, 679, 1816, 544, 2392, 1862, 1364, 2033, 1296, 2200, 2017, 2208, 1175, 1233, 1653, 1463, 955, 2087, 1698, 1064, 1958, 271, 1135, 1385, 870, 507, 2182, 1223, 1288, 2008, 398, 1234, 965, 662, 868, 1483, 1489, 647, 1232, 2175, 1984, 222, 840, 175, 176, 1261, 437, 557, 1082, 1633, 426, 672, 1379, 872, 1973, 1822, 144, 692, 1820, 1821, 1312, 2077, 161, 140, 1696, 678, 780, 73, 74, 1292, 1466, 34, 119, 2043, 155, 1837, 118, 1451, 598, 1158, 1153, 1663, 1546, 835, 177, 1720, 749, 1400, 1897, 1246, 1245, 1939, 897, 2137, 111, 2206, 1585, 880, 1845, 777, 403, 26, 523, 1951, 2144, 1494, 2921, 385, 1930, 609, 1748, 1425, 1988, 2000, 148, 592, 1870, 674, 1049, 510, 2294, 2316, 1829, 1838, 1915, 1172, 687, 1710, 80, 1987, 428, 602, 623, 2220, 775, 988, 1582, 1979, 928, 807, 1322, 529, 1891, 465, 1719, 808, 1048, 1024, 824, 745, 617, 985, 1259, 1136, 2927, 1534, 1350, 1452, 1620, 802, 913, 1180, 354, 1813, 522, 983, 1121, 421, 1867, 1198, 416, 1840, 1812, 2066, 212, 933, 1676, 1634, 2059, 1541, 1338, 1520, 1955, 178, 249, 1418, 1251, 1176, 1417, 1899, 1454, 1055, 1962, 1015, 1124, 1547, 2266, 1230, 1543, 1609, 1744, 2110, 1553, 2922, 940, 1639.657, 2141, 1619, 143, 1368, 1149, 292, 887, 113, 105, 1742, 2280, 1949, 475, 1850, 1901, 845, 2100, 273, 1319, 2036, 468, 1341, 545, 526, 769, 1554, 1651, 932, 1060, 1647, 1220, 1200, 1932, 1931, 1935, 491, 514, 294, 1227, 236, 408, 1847, 2089, 873, 874, 1046, 994, 1745, 173, 1700, 2097, 341, 342, 1648, 853, 744, 786, 1355, 1925, 1313, 1991, 373, 1171, 1551, 1794, 2091, 1615, 1439, 1911, 149, 1080, 1, 618, 471, 1844, 1697, 972, 353, 2114, 1283, 1448, 267, 1123, 1206, 497, 425, 1330, 1888, 1050, 2253, 1273, 1974, 1907, 818, 621, 890, 1374, 1747, 162, 1371, 1125, 1031, 1085, 1864, 1565, 179, 946, 1372, 945, 1449, 1517, 1186, 2078, 1318, 1264, 1351, 1640, 1667, 1248, 1637, 1576, 1575, 1493, 646, 1577, 1579, 1574, 329, 2069, 1914, 1173, 343, 304, 306, 307, 308, 1684, 433, 413, 1159, 429, 2010, 1490, 1670, 921, 882, 1051, 2347, 567, 422, 1304, 849, 1853, 1057, 1295, 2055, 603, 1090, 463, 1841, 1129, 1959, 604, 850, 454, 460, 2053, 812, 1468, 1921, 1896, 1982, 1503, 295, 1969, 2130, 411, 183, 375, 969, 1628, 634, 1555, 847, 1666, 240, 1320, 1706, 1528, 241, 242, 157, 156, 804, 1432, 1008, 1068, 658). 4. Model Number: 722013. No UDI. Serial Numbers: 505, 217, 313, 492, 34, 153, 410, 360, 290, 74, 83, 580, 160, 404, 126, 244, 106, 346, 461, 307, 1, 442, 435, 293, 297, 46, 289, 638, 342, 69, 267, 214, 402, 113, 86, 603, 82, 149, 424, 140, 254, 255, 266, 475, 518, 519, 303, 194, 115, 150, 496, 599, 441, 491, 124, 151, 179, 550, 377, 575, 562, 178, 309, 601, 327, 73, 77, 264, 78, 308, 141, 357, 85, 40, 216, 637, 422, 174, 392, 109, 218, 228, 511, 389, 152, 479, 262, 61, 401, 497, 84, 125, 241, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 205, 246, 43, 639, 35, 480, 304, 147, 15, 52, 283, 168, 171, 265, 272, 332, 509, 444, 400, 292, 117, 598, 415, 454, 222, 215, 335, 416, 47, 384, 559, 361, 358, 549, 476, 133, 36, 315, 31, 490, 417, 48, 276, 247, 618, 390, 157, 53, 238, 525, 17, 528, 224, 76, 585, 271, 172, 50, 544, 570, 359, 296, 530, 232, 478, 457, 547, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 107, 138, 227, 318, 341, 225, 29, 508, 103, 434, 473, 135, 551, 557, 541, 294, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 523, 182, 574, 139, 137, 250, 563, 502, 450, 436, 275, 524, 354, 510, 395, 458, 261, 595, 586, 535, 569, 425, 334, 344, 355, 356, 465, 345, 501, 522, 64, 396, 208, 408, 555, 394, 57, 520, 493, 201, 366, 527, 65, 449, 167, 70, 312, 321, 161, 324, 311, 176, 181, 554, 104, 459, 130, 325, 470, 440, 144, 28, 385, 403, 81, 134, 487, 256, 374, 405, 380, 367, 108, 352, 71, 455, 468, 60, 301, 299, 191, 300, 302, 239, 243, 110, 111, 158, 378, 223, 343, 165, 453, 291, 532, 364, 370, 22, 193, 336, 132, 236, 163, 2266, 368, 177, 98, 156, 443, 259, 540. 5. Model Number: 722022. No UDI. Serial Number: 6. 6. Model Number: 722023. No UDI. Serial Numbers: 27, 116, 12, 175, 98, 35, 72, 142, 46, 64, 110, 49, 124, 66, 117, 109, 42, 138, 82, 83, 127, 75, 118, 41, 33, 146, 121, 119, 70, 112, 47, 137, 25, 114, 105, 90, 107, 74, 5, 9, 4, 14, 13, 16, 132, 88, 73, 99, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150, 108, 100, 95, 34, 54, 85, 87, 94, 57, 30, 130, 58, 86, 125, 96, 3, 103, 10, 31, 106, 67. 7. Model Number: 722025. No UDI. Serial Numbers: 3, 2, 6.

510(k) numbers

K161563

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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