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.
Enforcement
- Recall Number
- Z-2503-2025
- Event ID
- 97249
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2025
- Initiation Date
- August 1, 2025
- Classification Date
- September 3, 2025
- Address
- Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands
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.
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.
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.
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.
1,006 units