Safety Alert: Class II: 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.

healthClass IIRecalled on Sep 10, 2025

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1

🔢 1,006 units

Sold At: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.(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.)

Recall #: FDA-DEVICE-Z-2503-2025

Source: FDA-ENFORCEMENT

Product Identification

Lot/Batch Codes:: 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.

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Summary

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.

What to do next

1Stop using this product - may cause temporary or medically reversible health problems
2Check with retailer or manufacturer for recall status and remedy options
3Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. for return or refund information
4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.