Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as t...
FDA Recall #Z-2503-2025 — Class II — August 1, 2025
Product Description
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
Reason for Recall
Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.
Recalling Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,006 units
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
Code Information
1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 1225, 789, 1138, 445, 740, 152, 1411. 2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 35. 3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 168, 2198, 2184, 2606, 195, 161, 1956, 2256, 2070, 1502, 376, 1096, 1731. 4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 246, 2470. 5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 911, 1180, 936, 338, 660, 411, 992, 1210, 873, 1028, 921. 6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308. 7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 525, 823, 1141, 1078, 1811, 2092, 1641, 114, 2134, 1589, 1446, 1675, 1625, 1989, 2156, 455, 233, 2929, 2930, 749, 1080, 149, 854. 8. Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 580, 254, 78, 357, 428. 9. Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 164, 66. 10. Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 287, 825, 462, 192, 74, 191, 204, 155, 967, 1132, 205, 1246, 253, 156, 234, 233, 845, 122, 259, 185, 618, 531, 855, 235, 335, 1068, 843, 805, 646, 965, 258, 220, 602, 908, 221, 664, 109, 110, 116, 117, 115, 284, 389, 223, 694, 222, 436, 1192, 102, 914, 396, 704, 370, 201, 774, 696, 838, 344, 93, 1072, 601, 245, 1340, 604, 627, 190, 605, 935, 297, 98, 99, 100, 101, 544, 1129, 1268, 841, 1239, 1293, 648, 1038, 1231, 215, 683, 142, 1050, 224, 73, 608, 1051, 1052, 323, 324, 931, 265, 431, 654, 786, 617, 87, 990, 1101, 738, 1287, 75, 688, 151, 121, 78, 114, 79, 770, 909, 1000, 612, 319, 458, 381, 826, 716, 432, 244, 534, 807, 962, 986, 961, 638, 830, 759, 1115, 707, 271, 296, 257, 86, 926, 448, 536, 525, 682, 1218, 1273, 1156, 146, 343, 406, 722, 247, 970, 672, 824, 903, 1234, 1065, 673, 603, 888, 790, 758, 314, 304, 606, 263, 262, 457, 1222, 251, 441, 686, 1024, 1086, 992, 178, 1178, 435, 710, 592, 1245, 660, 345, 118, 1219, 333, 338, 360, 730, 551, 349, 727, 519, 133, 195, 196, 137, 528, 460, 529, 530, 126, 455, 542, 566, 978, 1201, 1202, 22, 277, 1317, 545, 723, 359, 846, 506, 197, 628, 1001, 119, 120, 857, 789, 481, 1138, 818, 734, 1137, 154, 313, 502. 11. Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 203, 123, 133, 284, 134, 222, 255, 106, 107, 234, 42, 179, 306, 307, 265, 267, 40, 332, 112, 305, 104, 231, 263, 342, 71, 351, 298, 116, 50, 29, 39, 49, 56, 152, 153, 202, 164, 160, 64, 99, 101, 254, 84, 297, 268, 77, 115, 114, 142, 30, 79, 38, 189, 300, 299, 247, 282, 70. 12. Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 596, 819, 1598, 316, 1946, 541, 565, 647, 674, 864, 710, 946, 949, 880, 1041, 447, 696, 166, 618, 313, 1214, 1846, 1978, 1649, 1256, 904, 242, 284, 1397, 1957, 207, 208, 526, 1677, 1756, 431, 2760, 601, 377, 1454, 1629, 275, 2933, 1340, 539, 356, 236, 237, 238, 422, 525, 350, 560, 1407, 272, 494, 80, 324, 282, 262, 1275, 406, 540, 1017, 840, 842, 136, 137, 793, 1130, 260, 636, 1446, 741, 768, 901, 1657, 1828, 1988, 638, 267, 654, 759, 1656, 1736, 1076, 929, 251, 989, 125, 211, 368, 499, 261, 1424, 1261, 1854, 924, 934, 1142, 1651, 774, 2174, 1463, 2846, 779, 1111, 519, 590, 453, 452, 680, 1074, 318, 11, 1191, 1212, 1211, 1269, 340, 481, 468, 317, 1774, 2502, 982, 339, 128, 655, 143, 1482, 1405, 140, 1448, 1413, 464, 2103, 139, 303, 476, 419, 521, 522, 1132, 580, 861, 1014, 256, 1266, 917, 1472, 2007, 2008, 1652, 1396, 1646, 1394, 254, 326, 1824, 343, 424, 435, 437, 543, 130, 987, 1187, 888, 273, 336, 375, 887, 533, 516, 449, 408, 1549, 376, 744, 1034, 420, 553, 110, 2261, 983, 627, 903, 1099, 1481, 363, 1690, 1233, 2206, 2310, 2506, 1331, 365, 203, 204, 1538, 625, 528, 310, 743, 445, 189, 292, 1466, 1200, 1374, 173, 161, 620, 1085, 361, 281, 475, 456, 1310, 315, 908, 672, 1522, 127, 132, 141, 145, 180, 1001, 463, 1484, 1835, 1244, 1022, 1004, 2173, 210, 1350, 1723, 1834, 2061, 2710, 591, 564, 407, 1751, 2284, 697, 364, 520, 2070, 582, 932, 930, 129, 218, 1483, 485, 176, 257, 1920, 962, 1809, 279, 459, 2196, 889, 556, 1149, 1095, 1870, 2253, 347, 909, 1498, 1650, 952, 160, 1569, 966, 306, 234, 213, 1202, 155, 222, 1122, 131, 133, 1855, 224, 490, 1570, 2249, 1869, 1447, 631, 637, 529, 493, 534, 491, 206, 1890, 205, 571, 197, 194, 195, 216, 217, 229, 227, 228, 305, 488, 1822, 1880, 209, 825, 1461, 2709, 2707, 579, 1634, 48, 1783, 498, 462, 1043, 142, 159, 280, 535, 2252, 158, 184, 185, 473, 489, 1826, 466, 671, 978, 402, 1499, 386, 1710, 1708, 1326, 1032, 454, 918, 1705, 914, 698, 1387, 666, 1995, 1889, 1983, 1568, 1980, 1845, 416, 394, 428, 1368, 426, 559, 684, 1333, 547, 550, 190, 973, 1068, 1069, 1630, 346, 1156, 632, 1567, 2407, 2422, 1428, 121, 333, 151, 372, 371, 911, 1633, 717, 1155, 265, 1343, 1439, 1600, 758, 942, 878, 1572, 1039, 763, 231, 663, 822, 1008, 430, 200, 1292, 1046, 728, 1088, 951, 440, 536, 1390, 1645, 827, 1378, 2372, 2373, 503, 2877, 2878, 2720, 853, 415, 1932, 9, 578, 2168, 635, 412, 575, 799, 766, 776, 434, 389, 380, 624, 119, 441, 1937, 105, 111, 687, 2076, 577, 954, 192, 1907, 810, 1128, 899, 1309, 472, 1112, 1307, 1308, 51, 767, 800, 826, 1021, 1235, 1329, 1462, 2314, 1135, 1134, 395, 1210, 2153, 29, 802, 1258, 398, 665, 328, 439, 1632, 322, 2112, 621, 226, 311, 1118, 611, 1120, 1604, 1602, 1601, 1603, 830, 1195, 352, 1268, 1125, 1879, 469, 775, 502, 2274, 113. 13. Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 91, 71, 110, 126, 21, 62, 88, 36, 100, 30, 63, 60, 94, 95, 56, 31, 107, 43. 14. Model Number/System Code (UDI); Serial Numbers: 722035(00884838054240); 85, 24, 101, 117, 21, 38, 177, 121, 183, 88, 57, 125, 119, 100, 165, 47, 52, 131, 124, 169, 46, 74, 30, 60, 59, 196, 216, 187, 34, 222, 72, 111, 128, 1, 96, 53, 160, 104, 191, 70, 154, 142, 134, 129, 65. 15. Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226); 39, 63, 42, 55, 78, 99, 60, 71, 115, 108, 67, 106, 118, 130, 49, 119, 126, 46, 37, 38, 48, 62, 35, 120, 41, 157, 96, 70, 137, 166, 34, 116, 72, 64. 16. Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 337, 22, 202, 71, 239, 186, 56, 24, 168, 129, 123, 259, 134, 38, 171, 264, 61, 99, 162, 65, 278, 277, 196, 23, 205, 212, 111, 49, 89, 150, 177, 60, 131, 377, 377, 206, 106, 223, 229, 288, 169, 125, 126, 320, 139, 213. 17. Model Number/System Code (UDI); Serial Numbers: 722059 (00884838059122); 7, 8.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.