CLASS II ONGOING Device recall · Reported 1 Oct 2025 · FDA Enforcement Report

Allura Xper Product Codes recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling Allura Xper Product Codes: 722010, 722026, 722003, distributed nationwide in the US. The recall was initiated on 3 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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 recalled1117 units (252 US, 865 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2623-2025
FDA event ID: 97501
Recalling firm: Philips Medical Systems Nederland B.v, Best, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 3 Sep 2025
FDA classified: 25 Sep 2025
Reported: 1 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

3 Sep 2025	Recall initiated by company
25 Sep 2025	Classified by FDA	+22 days
1 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Is Allura Xper Product Codes: 722010, 722026, 722003 recalled?

Yes. Philips Medical Systems Nederland B.v recalled Allura Xper Product Codes: 722010, 722026, 722003 on 3 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-2623-2025.

Why was it recalled?

Which lots are affected?

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;

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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