Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638,
Summary
The FDA issued a Class II for Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 51 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply un.
Details
Source
Device Recall
External ID
Z-2623-2025
Action Date
2025-10-01
Status
Ongoing
Category
device
Product Description
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Lot/Code Info: Product Codes: (1)722010, (2) 722026, (3) 722003; UDI-DI: (1) 00884838059030, (2) 00884838054189, (3) N/A; Serial numbers: (1) 764, 177, 662, 905, 480, 499, 833, 787, 1336, 839, 1048, 343, 1011, 917, 108, 671, 677, 468, 1132, 1025, 1226, 411, 1108, 1043, 1302, 160, 1309, 638, 527, 1442, 1109, 679, 467, 986, 1112, 968, 505, 286, 636, 946, 214, 755, 1365, 809, 763, 992, 521, 647, 1176, 67, 1123, 979, 1064, 931, 1209, 1210, 624, 1298, 290, 604, 605, 1126, 422, 1170, 882, 1128, 646, 395, 1233, 1234, 1235, 1236, 690, 698, 306, 478, 1041, 1042, 592, 780, 252, 873, 818, 1230, 1263, 69, 1370, 1369, 999, 728, 280, 488, 1310, 673, 683, 890, 641, 1373, 1040, 308, 360, 1297, 914, 1149, 794, 423, 1118, 878, 920, 1005, 1292, 1144, 453, 364, 792, 1283, 902, 651, 240, 788, 296, 1312, 1391, 1183, 921, 939, 1344, 572, 970, 585, 1181, 1078, 1279, 656, 668, 896, 342, 531, 33, 344, 1308, 1069, 1287, 477, 1261, 241, 298, 285, 694, 414, 714, 785, 601, 654, 1122, 301, 1198, 332, 666, 777, 608, 426, 924, 577, 265, 1047, 219, 959, 901, 552, 935, 1140, 64, 1213, 1015, 1016, 1017, 1018, 1194, 1192, 996, 1188, 1208, 1190, 233, 1211, 418, 1116, 1168, 806, 907, 887, 71, 400, 825, 1339, 1351, 1199, 1137, 713, 948, 1148, 502, 248, 596, 1304, 1197, 602, 1346, 1326, 134, 930, 302, 230, 231, 232, 991, 245, 509, 1093, 1124, 1349, 535, 941, 537, 712, 402, 1034, 1453, 748, 1368, 192, 1331, 447, 1367, 393, 1375, 506, 369, 856, 1191, 802, 706, 1381, 1364, 264, 613, 614, 247, 350, 1206, 490, 1325, 1380, 1165, 1285, 1215, 1256, 424, 1384, 971, 1254, 732, 425, 565, 541, 1360, 699, 759, 657, 658, 642, 696, 1252, 513, 1100, 707, 708, 1220, 734, 735, 736, 737, 469, 1366, 1223, 1353, 1374, 898, 1098, 1113, 1350, 1327, 1361, 1376, 1356, 319, 1163, 1355, 1242, 270, 267, 1091, 940, 578, 1095, 322, 273, 346, 371, 1385, 622, 483, 786, 380, 685, 686, 1086, 46, 1445, 1345, 776, 799, 711, 990, 957, 520, 984, 1225, 771, 1036, 282, 72, 1221, 222, 978, 847, 1151, 340, 653, 1083, 586, 1135, 911, 863, 253, 1180, 398, 49, 740, 625, 936, 631, 1155, 1303, 963, 1232, 496, 287, 299, 945, 915, 885, 297, 1315, 760, 401, 315, 1177, 1178, 811, 600, 692, 382, 828, 816, 769, 1241, 409, 1150, 944, 650, 300, 1111, 1196, 1022, 877, 758, 384, 797, 1276, 1157, 1278, 772, 415, 1216, 1273, 416, 1265, 967, 1452, 1294, 895, 88, 955, 1444, 998, 1012, 860, 494, 960, 1286, 861, 475, 356, 876, 1250, 157, 612, 1007, 1305, 800, 383, 906, 989, 680, 261, 1021, 951, 832, 474, 1266, 406, 1121, 1120, 404, 1053, 428, 579, 503, 493, 211, 217, 351, 528, 559, 1334, 58, 566, 589, 593, 594, 891, 1146, 1267, 328, 518, 568, 904, 700, 701, 810, 850, 842, 744, 1207, 1218, 855, 583, 362, 1313, 1077, 1300, 710, 972, 1076, 934, 1130, 858, 645, 529, 1448, 789, 1067, 1129, 1449, 975, 523, 626, 186, 1617, 223, 555, 598, 702, 1119, 1051, 137, 660, 741, 742, 1029, 1088, 1136, 844, 973, 1000, 394, 1171, 269, 277, 304, 558, 822, 476, 852, 880, 1044, 862, 804, 396, 254, 1182, 276, 320, 997, 1065, 952, 548, 753, 114, 330, 515, 909, 1152, 563, 312, 313, 121, 1193, 1092, 834, 184, 857, 697, 634, 1185, 1055, 782, 1096, 813, 368, 349, 781, 235, 549, 570, 388, 387, 386, 525, 66, 251, 278, 868, 185, 923, 687, 607, 817, 719, 501, 130, 1006, 516, 1147, 1446, 141, 599, 689, (2) 156, 253, 287, 394, 713, 74, 462, 192, 191, 204, 155, 205, 185, 618, 531, 235, 725, 368, 646, 663, 602, 221, 664, 110, 116, 115, 284, 389, 223, 694, 222, 374, 634, 622, 102, 396, 370, 201, 696, 344, 563, 233, 543, 93, 245, 234, 604, 190, 562, 98, 100, 101, 544, 561, 648, 215, 683, 600, 391, 323, 324, 444, 265, 431, 114, 654, 617, 378, 558, 738, 75, 688, 78, 614, 151, 79, 559, 319, 633, 458, 381, 400, 432, 335, 244, 484, 485, 121, 612, 534, 271, 261, 89, 575, 180, 632, 594, 296, 354, 619, 535, 539, 90, 571, 576, 626, 28, 150, 525, 682, 194, 322, 700, 377, 565, 285, 379, 308, 306, 429, 640, 641, 642, 709, 579, 708, 128, 29, 492, 464, 327, 62, 153, 397, 330, 651, 695, 328, 84, 398, 7, 420, 385, 69, 134, 581, 65, 681, 77, 404, 146, 96, 343, 388, 107, 720, 721, 722, 342, 589, 247, 216, 384, 292, 603, 673, 314, 95, 81, 684, 305, 606, 39, 262, 263, 383, 441, 686, 76, 42, 178, 365, 44, 435, 592, 163, 660, 523, 345, 118, 699, 333, 360, 414, 551, 349, 92, 519, 133, 208, 137, 419, 15, 149, 445, 460, 528, 136, 64, 293, 490, 520, 401, 405, 402, 631, 298, 493, 226, 423, 237, 510, 358, 97, 334, 621, 616, 346, 332, 507, 715, 463, 341, 762, 742, 171, 299, 337, 364, 382, 478, 325, 752, 572, 517, 724, 362, 446, 574, 689, 231, 434, 447, 459, 567, 650, 387, 509, 557, 418, 279, 376, 209, 511, 210, 591, 541, 586, 356, 611, 596, 578, 573, 584, 701, 500, 199, 132, 157, 610, 363, 652, 508, 217, 516, 583, 580, 125, 498, 88, 361, 471, 661, 303, 590, 741, 353, 690, 249, 227, 476, 496, 139, 148, 214, 421, 489, 625, 491, 1243, 487, 624, 393, 228, 269, 270, 372, 375, 425, 426, 427, 428, 449, 450, 472, 503, 687, 25, 570, 126, 164, 455, 542, 566, 1201, 532, 547, 706, 206, 466, 442, 443, 105, 38, 70, 106, 655, 669, 83, 160, 486, 198, 495, 469, 268, 568, 835, 40, 252, 477, 301, 188, 189, 1071, 183, 22, 187, 152, 316, 318, 277, 549, 545, 470, 569, 723, 359, 577, 585, 439, 440, 336, 456, 505, 179, 506, 504, 213, 408, 291, 286, 540, 197, 527, 526, 628, 524, 184, 461, 677, 678, 266, 658, 119, 348, 236, 161, 182, 717, 1313, 692, 412, 23, 411, 315, 481, 430, 17, 18, 294, 497, 424, 494, 174, 172, 143, 273, 43, 141, 33, 347, 104, 256, 546, 154, 351, 212, 302, 326, (3) 527, 1349, 1472, 746, 1700, 995, 1529, 92, 1266, 38532, 1001, 1637, 377, CM/0112/138, 763, 599, 1751, 1107, 1388, 2415, 1569, 1570, 1297, 1726, 2521, 1065, 265, 1592, 163, 1396, 1717, 1680, 281, 391, 1273, 1578, 1558, 369, 1176, 492, 1016, 1774, 807, 1325, 1230, 329, 1495, 1414, 205, 162, 321, 1585, 751, 990, 1646, 1784, 136, 1897, 548, 1293, 39, 1H059866, CV402, 1527, 245, 280, 116, 241, 1968, 1014, 1378, 1413, 85400, 863, 192, 1912, 813, 1804, 715, 716, 468, 1452, 948, 288, 1155, 895619, 519, 380, 1669, 388, 1327, 130, 190, 1247, A5E799D03, 1260, 1163, 1518;
Quantity Affected: 1117 units (252 US, 865 OUS)
Reason for Recall
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-03
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2623-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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