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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97501

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

Open FDA event record

Event summary

Timeline bucket
September 03, 2025
Product types
Device
Classifications
Class II
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

13 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 13

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

Z-2623-2025
Recall number
Z-2623-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
1117 units (252 US, 865 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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;

Distribution pattern

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.

device · product 2 of 13

Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2624-2025
Recall number
Z-2624-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
286 units (67 US, 219 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722011, (2) 722027, (3) 722005; UDI-DI: (1) 00884838059047, (2) 00884838054196, (3) N/A; Serial numbers: (1) 157, 268, 95, 107, 59, 319, 49, 170, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 87, 255, 171, 362, 168, 275, 344, 324, 163, 103, 215, 328, 286, 81, 293, 294, 224, 117, 334, 338, 146, 145, 266, 21, 202, 165, 367, 372, 340, 318, 98, 211, 158, 271, 204, 246, 206, 321, 295, 104, 217, 265, 261, 125, 282, 216, 333, 329, 230, 198, 244, 292, 180, 183, 314, 337, 341, 376, 377, 378, 259, 347, 287, 99, 233, 156, 71, 77, 188, 223, 238, 153, 129, 278, 118, 186, 108, 89, 258, 310, 274, 139, 141, 86, 300, 88, 309, 227, 220, 242, 166, 299, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 116, 112, 114, 43, 313, (2) 123, 133, 134, 183, 106, 169, 107, 42, 101, 209, 153, 40, 156, 112, 1, 104, 71, 175, 116, 174, 29, 50, 56, 152, 43, 49, 202, 178, 127, 39, 27, 64, 78, 99, 6, 86, 7, 145, 102, 44, 142, 30, 79, 38, 85, 181, 144, 177, 165, 201, 3, 68, 51, 21, 23, 24, 90, 171, 45, 122, 33, 137, 163, 150, 96, 155, 20, 166, 147, 139, 91, 136, 193, 69, 65, 168, 206, 158, 66, 75, 62, 138, 121, 18, 31, 131, 195, 192, 125, 148, 149, 46, 47, 135, 159, 100, 103, 110, 57, 274, 61, 36, 151, 300, 167, 60, 81, 126, 58, 184, 5, 188, 94, 154, 172, 35, 76, 95, 187, 170, 146, 162, 82, 117, 48, 205, 182, 132, (3) 212, 435, 128, 323, 269, 342, 531, 403, 287, 457, 373, 332, 374, 428, 75, 499, 511, 473, TPE, 333, 237, 338, SN545, 159, 100071298SN408, 96;

Distribution pattern

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.

device · product 3 of 13

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2625-2025
Recall number
Z-2625-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
2 units (1 US, 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722022, (2) 722033; UDI-DI: (1) 00884838059078, (2) 00884838054233; Serial numbers: (1) 6, (2) 1;

Distribution pattern

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.

device · product 4 of 13

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2626-2025
Recall number
Z-2626-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
2114 units (791 US, 1323 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722012, (2) 722028, (3) 722006; UDI-DI: (1) 00884838059054, (2) 00884838054202, (3) N/A; Serial numbers: (1) 919, 1581, 1117, 1001, 1673, 1712, 585, 517, 1545, 1715, 504, 757, 935, 1356, 1250, 1613, 2006, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 1804, 100, 1408, 590, 2508, 1279, 2509, 452, 2151, 1724, 2134, 481, 543, 893, 1455, 2085, 423, 1282, 2307, 1798, 1656, 990, 1806, 1871, 2506, 1652, 894, 2920, 1189, 1099, 1038, 1058, 566, 823, 1037, 924, 2319, 2310, 1610, 686, 2933, 2514, 1108, 500, 459, 1422, 1035, 84, 1649, 1895, 1900, 1723, 878, 2221, 464, 2496, 2222, 1515, 1731, 1017, 1020, 380, 1811, 527, 2171, 418, 1053, 1558, 1336, 601, 1014, 1265, 331, 389, 732, 751, 1324, 2276, 684, 2219, 814, 815, 1120, 297, 1713, 580, 1098, 1852, 1307, 1858, 758, 2054, 856, 1690, 1407, 480, 579, 1327, 695, 733, 1506, 1091, 1254, 797, 213, 1280, 828, 1118, 1249, 542, 1033, 2265, 490, 920, 1209, 470, 1075, 2203, 1396, 444, 2092, 597, 1269, 1002, 1023, 2264, 2234, 1805, 1192, 1823, 483, 484, 615, 2150, 892, 1478, 1262, 1688, 1961, 1062, 649, 650, 767, 1641, 1277, 2609, 1975, 316, 959, 1461, 489, 766, 639, 669, 671, 1583, 451, 625, 1047, 670, 1616, 1660, 1807, 1924, 511, 1714, 1406, 492, 352, 643, 577, 578, 1306, 855, 1456, 2269, 1078, 768, 2285, 1793, 1797, 1216, 948, 498, 1570, 2521, 1662, 2313, 1743, 2516, 1561, 1692, 2286, 2293, 1960, 616, 1508, 1084, 655, 1796, 1026, 2629, 1337, 685, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 531, 1586, 1617, 1904, 1354, 1918, 1906, 160, 383, 560, 2614, 1948, 1195, 518, 888, 1992, 323, 792, 2003, 2004, 174, 1832, 2166, 562, 1941, 859, 1593, 1608, 731, 520, 1328, 848, 2292, 1946, 1063, 611, 1587, 2308, 613, 1842, 205, 1799, 1665, 187, 1513, 2015, 2207, 2309, 319, 2161, 1116, 1993, 208, 1281, 1945, 1919, 110, 1735, 1326, 788, 488, 1519, 1533, 1334, 2013, 1405, 1141, 923, 925, 406, 1293, 513, 1446, 1625, 1675, 1148, 1181, 2515, 1305, 499, 1716, 476, 1657, 1045, 1630, 2610, 1827, 1923, 1516, 453, 2215, 574, 1611, 1559, 2924, 1686, 858, 1224, 1345, 2057, 1430, 1255, 1599, 2014, 2022, 1188, 1073, 1404, 1664, 103, 2063, 533, 1947, 1950, 594, 1467, 1596, 2607, 926, 756, 424, 1027, 1894, 2145, 2148, 234, 2065, 1477, 2227, 1177, 1645, 2522, 2156, 1167, 1595, 2469, 88, 1672, 1210, 1512, 1101, 1399, 1119, 952, 953, 954, 1661, 320, 455, 570, 1622, 1115, 1316, 1212, 976, 1746, 986, 971, 1594, 239, 640, 446, 1301, 2323, 430, 1542, 1607, 2454, 2149, 1211, 1004, 2046, 1044, 505, 2937, 310, 192, 314, 852, 1097, 1532, 1964, 2135, 1357, 589, 1092, 846, 963, 964, 1658, 1344, 1902, 1909, 1132, 1361, 1504, 1433, 1260, 2108, 837, 333, 1681, 2282, 328, 781, 1815, 922, 1333, 774, 1492, 2047, 1855, 1817, 1562, 627, 2005, 930, 1956, 967, 2168, 910, 1168, 931, 2098, 1421, 863, 1040, 409, 1072, 1332, 2042, 57, 995, 993, 2350, 1460, 1971, 838, 914, 2352, 1156, 180, 1444, 2314, 2335, 795, 1865, 628, 809, 2945, 2406, 1376, 2244, 2169, 194, 664, 482, 1363, 288, 462, 1980, 1580, 395, 1423, 548, 2455, 1887, 1157, 1485, 876, 1592, 2346, 2074, 2072, 1256, 573, 1917, 2418, 2674, 60, 2547, 1833, 2587, 630, 1825, 1839, 1591, 2462, 502, 2599, 98, 1196, 1495, 2139, 2490, 477, 2204, 779, 2558, 2385, 770, 799, 1703, 2178, 541, 1480, 2553, 2545, 608, 2356, 1297, 2026, 652, 1150, 1349, 911, 2585, 871, 1678, 2451, 2413, 2076, 2127, 1671, 1081, 1028, 2056, 1708, 830, 2479, 1978, 2363, 2102, 663, 2474, 839, 2298, 1151, 1152, 1626, 2403, 1882, 569, 688, 2016, 2434, 1366, 2296, 544, 1481, 1390, 419, 2504, 2197, 1436, 2336, 728, 785, 355, 1698, 793, 794, 1556, 1654, 2539, 1736, 2601, 2604, 1967, 622, 1691, 2365, 2366, 2291, 2299, 2501, 1669, 2634, 1471, 737, 1879, 581, 2121, 1937, 2388, 2180, 1342, 647, 867, 1288, 1489, 1178, 1874, 2175, 479, 2537, 1237, 1381, 2274, 398, 2523, 2491, 2459, 1965, 1818, 941, 1147, 803, 1699, 798, 441, 1089, 2429, 1463, 1479, 534, 1138, 2401, 752, 2344, 1536, 2249, 2532, 2410, 772, 1021, 1382, 2441, 2326, 2345, 1999, 2405, 1309, 2438, 1572, 2173, 2174, 1836, 2549, 2583, 730, 2031, 1976, 2118, 1079, 1530, 1875, 593, 2394, 2527, 1412, 1548, 2384, 2153, 748, 2576, 1567, 2411, 1064, 1287, 1795, 635, 2358, 2798, 509, 2577, 1484, 667, 2524, 2443, 2348, 2442, 2330, 659, 528, 1711, 2128, 1056, 1134, 1862, 2470, 1348, 2481, 443, 806, 2396, 407, 1898, 2460, 2467, 405, 2493, 2494, 980, 2058, 1169, 1223, 629, 763, 1535, 2393, 2615, 432, 966, 987, 1631, 2525, 2392, 1233, 2290, 2482, 1234, 2017, 2894, 2526, 2398, 2507, 599, 1705, 1721, 2427, 753, 1624, 2387, 619, 2424, 1462, 810, 771, 266, 2122, 755, 2543, 2647, 1834, 866, 2208, 743, 2633, 1977, 2461, 693, 902, 2613, 2555, 2270, 917, 2371, 2575, 2342, 998, 1131, 2155, 1174, 1375, 982, 1268, 662, 2487, 1885, 2341, 2449, 2028, 2033, 2338, 2389, 679, 376, 1926, 916, 2297, 1623, 660, 1076, 2007, 936, 2453, 2531, 2351, 2546, 2552, 1059, 2616, 2301, 2589, 2188, 588, 2087, 895, 1377, 272, 648, 1860, 2372, 2373, 587, 1614, 2457, 2399, 661, 554, 2608, 1830, 2205, 1086, 2117, 813, 2471, 1819, 2327, 2412, 572, 1861, 2489, 1695, 2343, 726, 2391, 2103, 2414, 2415, 2437, 817, 524, 415, 2095, 2082, 2619, 1145, 631, 1122, 738, 2464, 2593, 2421, 746, 2252, 1222, 112, 2124, 2488, 185, 2404, 2375, 2182, 400, 2340, 1203, 1202, 2080, 869, 2502, 2229, 1415, 764, 2422, 742, 2325, 2067, 2364, 1135, 1881, 2093, 2034, 539, 805, 360, 680, 1450, 2538, 555, 2536, 2492, 1284, 1266, 2094, 1364, 1093, 2008, 773, 2730, 1998, 965, 2112, 556, 1483, 868, 2541, 2024, 2439, 2440, 1232, 1737, 1702, 410, 2554, 2198, 2278, 833, 2591, 2123, 1653, 2177, 1367, 2195, 1388, 2495, 1391, 1261, 557, 840, 437, 1082, 426, 1633, 672, 1379, 872, 692, 1820, 144, 1821, 972, 1837, 1696, 2045, 2919, 2043, 678, 780, 1290, 2517, 246, 34, 1939, 2520, 1585, 835, 1245, 1930, 1897, 2144, 1246, 1494, 1158, 1951, 897, 2137, 2519, 1663, 1153, 609, 2000, 1400, 403, 1013, 2934, 1748, 1845, 1425, 1988, 2312, 777, 749, 1720, 1546, 393, 592, 1870, 510, 2256, 2172, 623, 2316, 2220, 1985, 687, 1915, 1829, 1710, 918, 602, 1322, 745, 1891, 1979, 808, 1719, 465, 1024, 988, 1582, 807, 1048, 529, 617, 834, 985, 2627, 1620, 1121, 421, 1136, 2927, 2918, 2011, 1452, 1534, 1813, 1176, 1520, 1949, 1955, 1541, 1901, 1639, 536, 2266, 2497, 657, 1198, 1634, 1899, 1338, 2498, 1553, 2625, 178, 1840, 212, 2066, 2458, 1619, 1812, 1055, 1251, 1418, 956, 2090, 887, 2100, 1543, 1744, 933, 1676, 845, 2110, 2141, 2505, 292, 1547, 1962, 1124, 2922, 1149, 1319, 2036, 857, 1346, 408, 1847, 2089, 873, 874, 994, 1046, 1700, 1991, 853, 2084, 2362, 342, 2359, 1355, 191, 537, 2360, 2361, 786, 744, 1925, 373, 2097, 1171, 1551, 1794, 2091, 1080, 1615, 1, 618, 1439, 312, 1844, 1911, 1697, 2114, 1283, 497, 1448, 1206, 1123, 1974, 425, 1888, 1907, 1374, 1747, 1264, 1517, 1318, 1085, 946, 2078, 945, 1565, 1372, 1125, 1557, 1186, 645, 1864, 1371, 1449, 1351, 1031, 1574, 1640, 1575, 1576, 1573, 1493, 1248, 1577, 646, 1579, 1403, 1914, 1173, 1227, 1931, 1060, 514, 1651, 491, 932, 1554, 1200, 1647, 1341, 1932, 1220, 526, 1935, 769, 1684, 2602, 2513, 433, 2628, 413, 2606, 327, 2010, 2347, 1051, 567, 422, 1304, 1853, 1057, 1295, 2055, 463, 1090, 1968, 1841, 603, 1959, 1129, 604, 454, 460, 1555, 1666, 1896, 1921, 1320, 1503, 1982, 1706, 295, 1468, 812, 2053, 1008, 804, 658, 1068, 1432, (2) 819, 774, 316, 541, 565, 647, 674, 864, 710, 880, 949, 237, 238, 356, 696, 793, 618, 313, 329, 1024, 904, 284, 167, 207, 208, 526, 479, 431, 601, 869, 377, 275, 2933, 900, 52, 66, 539, 1, 272, 494, 80, 282, 990, 262, 522, 406, 548, 1017, 586, 530, 136, 940, 938, 1076, 929, 251, 731, 989, 981, 350, 125, 368, 971, 499, 211, 261, 924, 934, 721, 1002, 779, 518, 519, 590, 1058, 452, 811, 543, 680, 668, 11, 318, 118, 343, 437, 205, 340, 481, 806, 274, 805, 468, 906, 317, 982, 592, 655, 143, 140, 464, 893, 139, 552, 303, 476, 419, 521, 531, 1014, 861, 580, 256, 818, 254, 326, 122, 324, 130, 877, 987, 995, 267, 866, 895, 128, 449, 516, 408, 373, 154, 956, 496, 376, 744, 473, 630, 785, 553, 110, 983, 627, 903, 784, 422, 525, 363, 260, 339, 781, 809, 678, 528, 560, 743, 445, 161, 189, 292, 720, 173, 620, 361, 281, 475, 315, 908, 672, 132, 141, 145, 180, 570, 463, 1244, 1004, 538, 210, 564, 558, 407, 697, 364, 879, 930, 932, 882, 129, 218, 451, 485, 176, 257, 962, 556, 998, 691, 215, 459, 889, 729, 160, 966, 306, 213, 692, 925, 994, 131, 133, 138, 224, 48, 490, 968, 67, 638, 631, 637, 529, 493, 491, 867, 891, 561, 209, 825, 579, 498, 462, 677, 1043, 142, 280, 159, 169, 535, 386, 158, 922, 184, 185, 489, 466, 671, 217, 194, 197, 227, 402, 559, 967, 973, 1069, 1032, 454, 918, 821, 698, 1051, 675, 741, 768, 910, 666, 547, 550, 416, 394, 636, 901, 426, 1035, 684, 190, 840, 842, 625, 166, 346, 632, 71, 382, 121, 549, 874, 229, 228, 333, 372, 151, 695, 371, 911, 1030, 717, 265, 758, 942, 742, 878, 763, 663, 905, 64, 628, 430, 200, 212, 63, 788, 1008, 1046, 944, 607, 1006, 870, 505, 2924, 770, 997, 748, 247, 460, 728, 951, 440, 536, 264, 30, 298, 300, 993, 405, 639, 467, 546, 855, 823, 835, 948, 2233, 1091, 760, 999, 1038, 487, 1987, 2069, 1594, 503, 915, 510, 603, 604, 876, 711, 708, 1065, 755, 615, 988, 1464, 1512, 507, 508, 735, 736, 737, 838, 969, 907, 1325, 612, 323, 853, 126, 201, 555, 702, 321, 1027, 933, 415, 9, 104, 38, 578, 414, 413, 13, 986, 765, 112, 824, 120, 221, 374, 1443, 661, 980, 165, 164, 1669, 574, 747, 635, 91, 514, 412, 182, 330, 480, 232, 816, 193, 780, 813, 709, 926, 233, 244, 32, 35, 1042, 40, 799, 163, 641, 766, 776, 297, 434, 389, 380, 624, 676, 119, 441, 105, 687, 523, 576, 577, 43, 954, 192, 899, 179, 54, 472, 295, 745, 123, 455, 718, 777, 1517, 730, 492, 762, 851, 568, 1047, 392, 963, 856, 168, 1097, 162, 716, 613, 857, 852, 337, 609, 249, 921, 544, 270, 970, 81, 527, 937, 767, 800, 826, 1021, 679, 301, 150, 156, 919, 606, 557, 483, 395, 1037, 98, 673, 103, 622, 354, 657, 599, 693, 752, 366, 276, 947, 898, 605, 427, 334, 245, 199, 1210, 442, 444, 1302, 782, 939, 617, 186, 1071, 1075, 794, 965, 614, 764, 432, 501, 1704, 367, 545, 438, 832, 286, 99, 29, 802, 398, 23, 608, 1070, 37, 439, 423, 235, 433, 322, 868, 694, 219, 754, 175, 642, 670, 727, 725, 387, 726, 722, 621, 724, 723, 974, 259, 34, 314, 860, 458, 756, 410, 269, 296, 705, 703, 704, 707, 643, 226, 623, 597, 355, 291, 311, 266, 792, 551, 116, 790, 611, 79, 170, 171, 24800-10, 753, 830, 320, 690, 600, 701, 411, 27, 484, 302, 335, 795, 773, 338, 659, 660, 863, 10, 1067, 115, 640, 602, 198, 290, 814, 341, 191, 875, 482, 153, 309, 778, 650, 562, 353, 585, 651, 652, 248, 362, 1079, 738, 319, 506, 2035, 77, 801, 370, 443, 183, 713, 964, 504, 187, 327, 658, 157, 883, 287, 685, 834, 797, 1040, 41, 360, 278, 955, 783, 14, 469, 502, 381, 1018, 975, 803, 733, 113, 225, 588, 573, 844, 845, 846, 1720, 843, 715, 712, 1785, 714, 36, 2490, 149, (3) 530, 1473, 316, 2087, 1637, 317, 1589, 1445, 2097, 810, 1928, 722, 498, 1457, 2536, D902-214-00, 920, 1875, 1520, 2608, 2066, CV.271, 1755, 1120, 904, 1754, 1227, 2574, 1733, 2102, 638, 2002, 723, 2112, 1732, 1870, 674, 1720, 1476, 1935, 226, 1631, 1235, 1469, 1830, 2184, 1448, 551, 1511, 353, 1845, 1653, 633056, 1889, 372, 1648, 722008-358, 1790, 1100, 1373, 1270, 1591, 1022, 768, 2304, 2371, 336, 351, 352, 2046, 555, 125, 1255, 1712, 666, 284, 2416, 516, 455, 1787, 417, 1819, 1880, 867, 1003, 2488, 380, 2438, 1031, 2095, 1784, 2115, 1530, 2245, 408, 245, 428, 1817, 1891, 2061, 833, 2278, 2348, 477, 1554, 1763, 902, 2307, 1561, 1916, 102, 1998, 1948, 2293, 2369, SN002458/100099178, 1692, 2015, 164, 1791, 1668, 585, 2171, PSO.6002064, 259, 1949, 2079, 1568, 241, 424, 872, CV619, 233, 1551, 2010, 89, 940, 2598, 457, 799, 866, 2124, 346, 2520, 2475, 1264, 1687, 1504, 1652, 1203, 519, 100079164-1971, 1213, 1509, 1708, 994, 31, 123456, NA, 1350, 83491, 33, 1533, 1219, 460, 2230, 1618, 717, 1539KR, 1876, 1021, 1559KR, 594, 2528, 2517, 1557, 1408, 462, 1193, 1605;

Distribution pattern

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.

device · product 5 of 13

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2627-2025
Recall number
Z-2627-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
268 units (102 US, 166 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722013, (2) 722008; UDI-DI: (1) 00884838059061, (2) N/A; Serial numbers: (1) 505, 313, 34, 153, 410, 360, 290, 241, 404, 126, 244, 106, 346, 383, 461, 307, 442, 435, 293, 289, 267, 214, 402, 86, 603, 149, 424, 140, 254, 255, 266, 518, 519, 303, 115, 150, 129, 496, 441, 124, 151, 550, 575, 562, 178, 330, 309, 601, 308, 264, 268, 141, 175, 85, 216, 422, 174, 228, 511, 152, 561, 262, 626, 497, 170, 379, 125, 564, 426, 495, 500, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 246, 639, 304, 147, 607, 567, 168, 171, 265, 332, 295, 589, 444, 447, 400, 384, 538, 117, 620, 624, 623, 215, 416, 415, 47, 335, 619, 598, 361, 358, 549, 133, 476, 315, 616, 630, 417, 490, 528, 525, 247, 618, 372, 613, 478, 544, 585, 608, 296, 570, 547, 138, 318, 345, 139, 473, 388, 434, 502, 586, 334, 411, 501, 458, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 250, 595, 406, 355, 57, 394, 535, 569, 522, 465, 533, 412, 95, 344, 354, 425, 542, 207, 555, 524, 574, 366, 527, 325, 470, 440, 144, 403, 448, 134, 380, 487, 374, 256, 405, 367, 455, 302, 300, 299, 239, 506, 243, 324, 311, 70, 161, 449, 321, 176, 181, 554, 167, 130, 378, 158, 237, 453, 165, 532, 223, 343, 291, 370, 193, 163, 526, 236, 156, 368, 499, 443, 540, 259, (2) 224, 105, 312, 197, 264, 294, 246, 231, 521, 413, 18, 19, 267, 487, 69, 386, 205, 416, 513, 337, 327, 122, 259, 150, 547, 408, 160, 388, 283, 359, 435, 370, 323, 128, 455, 266, 468, 46;

Distribution pattern

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.

device · product 6 of 13

Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2628-2025
Recall number
Z-2628-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
174 units (45 US, 129 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722023, (2) 722035, (3) 722015; UDI-DI: (1) 00884838059085, (2) 00884838054240, (3) N/A; Serial numbers: (1) 27, 116, 12, 175, 98, 35, 142, 179, 46, 64, 110, 124, 66, 117, 109, 42, 138, 82, 83, 127, 75, 118, 41, 121, 70, 119, 112, 25, 159, 137, 47, 173, 114, 167, 164, 4, 16, 14, 107, 9, 13, 105, 5, 132, 2, 21, 38, 102, 52, 84, 56, 150, 144, 149, 134, 60, 15, 68, 126, 79, 145, 123, 135, 157, 32, 53, 152, 108, 95, 34, 87, 94, 57, 58, 165, 86, 125, 103, 3, 31, (2) 123, 38, 85, 101, 117, 21, 57, 145, 119, 100, 47, 127, 52, 131, 124, 89, 46, 74, 59, 121, 34, 72, 111, 128, 84, 10, 11, 40, 108, 144, 266, 80, 113, 130, 122, 109, 96, 53, 58, 104, 56, 69, 71, 75, 76, 208, 110, 149, 49, 105, 82, 136, 15, 146, 48, 16, 95, 64, 17, 106, 81, 29, 116, 102, 13, 12, 32, 35, 62, 107, 142, 43, 77, 94, 33, 37, 61, 51, 50, 19, 28, 97, 148, 114, 3, 151, 79, 129, 65, 25, 26, 103, 98, (3) 3;

Distribution pattern

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.

device · product 7 of 13

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2629-2025
Recall number
Z-2629-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
5 units (2 US, 3 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Codes: (1)722020, (2) 722025; UDI-DI: (1) N/A, (2) 00884838059108; Serial numbers: (1) 6, 4, (2) 2, 3, 6;

Distribution pattern

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.

device · product 8 of 13

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2630-2025
Recall number
Z-2630-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
75 units (26 US, 49 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722038; UDI-DI: 00884838054226; Serial numbers: 39, 63, 42, 55, 67, 99, 60, 71, 115, 78, 106, 118, 130, 49, 119, 126, 173, 37, 38, 48, 62, 35, 137, 131, 70, 46, 102, 122, 121, 113, 152, 111, 138, 14, 127, 94, 93, 132, 92, 89, 88, 66, 30, 58, 29, 170, 28, 47, 104, 112, 50, 116, 79, 98, 31, 3, 123, 32, 5, 9, 27, 105, 69, 40, 75, 11, 73, 133, 110, 72, 117, 68, 64, 45, 109;

Distribution pattern

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.

device · product 9 of 13

Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2631-2025
Recall number
Z-2631-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
3 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722039; UDI-DI: 00884838054271; Serial numbers: 2, 4, 5;

Distribution pattern

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.

device · product 10 of 13

Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2632-2025
Recall number
Z-2632-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
45 units (11 US, 34 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722029; UDI-DI: 00884838054219; Serial numbers: 71, 7, 62, 36, 21, 30, 63, 129, 56, 57, 31, 24, 32, 39, 69, 34, 45, 37, 23, 44, 40, 38, 75, 35, 61, 53, 25, 58, 85, 27, 46, 19, 14, 20, 52, 70, 78, 29, 59, 49, 50, 81, 80, 47, 43, ;

Distribution pattern

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.

device · product 11 of 13

Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2633-2025
Recall number
Z-2633-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
98 units (23 US, 75 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722058; UDI-DI: 00884838059115; Serial numbers: 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109, 100, 124, 94, 23, 111, 110, 108, 32, 161, 89, 18, 19, 409, 66, 55, 40, 72, 15, 9, 25, 81, 119, 60, 164, 7, 101, 106, 145, 136, 137, 76, 112, 130, 45, 144, 64, 79, 29, 21, 16, 10, 90, 70, 153, 34, 43, 31, 75, 20, 63, 117, 73, 116, 148, 95, 68, 139, 67, 93, 354, 58, 115, 154, 92, 142, 256, 128, 141, 78, 183, 125, 126, 143, 170, 30, 11, 127, 27, 97, 48;

Distribution pattern

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.

device · product 12 of 13

Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2634-2025
Recall number
Z-2634-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
1 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722059; UDI-DI: 00884838059122; Serial numbers: 2;

Distribution pattern

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.

device · product 13 of 13

Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2635-2025
Recall number
Z-2635-2025
Initiated
September 03, 2025
Classification
Class II
Status
Ongoing
Quantity
46 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: 722031; UDI-DI: N/A; Serial numbers: 155, 150, 87, 88, 109, 97, 138, 86, 152, 135, 153, 35, 76, 133, 173, 124, 92, 166, 61, 130, 116, 117, 110, 112, 113, 89, 90, S01H000984, 177, 164, 165, 161, 162, 163, 100, 174, 167, 158, 134, 136, 180, 115, 83, 77, 94, 85;

Distribution pattern

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.