Class II FDA device recall · Z-0676-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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.

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type: Devices
Recall number: Z-0676-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Best
Recall initiated: 2024-11-11

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0676-2025 · Source: openFDA enforcement.