Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresp

Summary

The FDA issued a Class II for Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starti.

Details

Product Description

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

Lot/Code Info: 1. Model Number/System Code (UDI); Serial Numbers: 722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 120, 153, 96, 108. 2. Model Number/System Code (UDI); Serial Numbers: 722064 (00884838085282); 64, 260, 261, 335, 218, 267, 270, 258, 35, 10, 111, 82, 125, 94, 278, 36, 55, 12, 57, 69, 484, 451, 497, 155, 272, 490, 132, 70, 251, 226, 290, 186, 48, 373. 3. Model Number/System Code (UDI); Serial Numbers: 722067 (00884838085350); 150, 69, 221, 148, 42, 98, 123, 277, 92, 103, 41, 214, 173, 172, 163, 128, 151, 22, 23, 268, 112, 97, 243, 45, 108, 113, 127, 176, 165, 33, 30, 206, 203, 48, 149, 251, 262. 4. Model Number/System Code (UDI); Serial Numbers: 722068 (00884838085367); 213, 111, 85, 89, 320, 73, 308, 172, 295, 406, 285, 413, 322, 324, 184, 442, 279, 361, 490, 42, 103, 520, 470, 472, 457, 400, 547, 510, 239, 275, 265, 365, 481, 62, 552, 44, 158, 36, 276, 68, 551, 516, 372, 46, 185, 515, 347, 416, 242, 219, 299, 126, 211, 468, 238, 568, 583, 69, 60, 426, 427, 93, 303, 302, 141. 5. Model Number/System Code (UDI); Serial Numbers: 722078 (00884838085251); 465, 143, 278, 402, 290, 524, 412, 166, 539, 532, 291, 415, 753, 441, 305, 289, 803, 399, 536, 537, 478, 479, 224, 163, 719, 364, 239, 383, 829, 513, 661, 215, 677, 709, 410, 269, 185, 902, 360, 546, 294, 906, 603, 870, 523, 598, 317, 535, 359, 436, 165, 733, 218, 204, 205, 206, 888, 923, 197, 195, 797, 444, 222, 489, 361, 362, 30, 223, 584, 962, 893, 27, 977, 156, 909, 953, 182, 958, 847, 959, 610, 490, 103, 184, 506, 23, 112, 199, 1047, 1074, 850, 643, 319, 547, 879, 572, 38, 865, 881, 261, 472, 368, 369, 243, 244, 731, 202, 442, 351, 636, 777, 40, 477, 134, 341, 563, 633, 286, 336, 512, 158, 357, 397, 896, 281, 52, 366, 190, 617, 496, 461, 463, 270, 528, 638, 529, 431, 712, 714, 219, 203, 575, 498, 577, 574, 139, 178, 179, 265, 264, 266, 511, 526, 746, 1082, 426, 36, 242, 300, 301, 795, 32, 241, 49, 51, 50, 250, 145, 774, 785, 474, 475, 452, 789, 552, 157, 818, 460, 459, 352, 46, 39, 311, 312, 277, 455, 608, 878, 220, 221, 321, 533, 699, 877. 6. Model Number/System Code (UDI); Serial Numbers: 722079 (00884838085268); 942, 948, 702, 703465, 1316, 1042, 465, 674, 703413, 1142, 1090, 526, 439, 637, 455, 334, 875, 737, 599, 29, 704281, 801, 671, 1387, 981, 1211, 1213, 499, 1230, 708, 496, 903, 887, 912, 1041, 703324, 528, 703584, 738, 351, 820, 32, 1411, 537, 445, 428, 587, 1290, 251, 1402, 318, 273, 877, 854, 897, 896, 836, 891, 940, 297, 483, 689, 717, 396, 860, 840, 790, 862, 774, 703344, 1436, 629, 1049, 1355, 1414, 703404, 703387, 703317, 703540, 58, 810, 939, 634, 53, 57, 841, 1282, 703310, 1100, 703314, 54, 703408, 246, 890, 703409, 658, 776, 703495, 18, 314, 828, 1323, 645, 646, 325, 731, 262, 1252, 703418, 474, 481, 800, 1359, 1358, 1360, 809, 1258, 1006, 602, 335, 837, 472, 703559, 342, 344, 345, 343, 1232, 1226, 1237, 1236, 34, 1400, 863, 987, 703389, 1391, 1043, 905, 577, 714, 573, 805, 228, 30, 366, 543, 921, 1200, 1222, 353, 703379, 703402, 350, 673, 669, 1212, 1285, 1216, 416, 290, 272, 703306, 35, 43, 40, 1270, 274, 466, 1155, 1033, 703356, 284, 703685, 703550, 703380, 703381, 332, 331, 330, 679, 845, 846, 328, 329, 783, 1016, 1017, 74, 1077, 37, 293, 952, 312, 703351, 703384, 759, 557, 1169, 756, 1306, 703597, 703611, 1129, 234, 75, 316, 740, 1104, 703653, 803, 1388, 67, 1133, 319, 76, 760, 966, 632, 1082, 421, 704131, 704252, 704009, 704215, 1181, 703815, 703330, 782, 1372, 703713, 725, 907, 901, 960, 542, 703470, 1428, 1037, 215, 1035, 703463, 1261, 703321, 831, 832, 410, 224, 495, 340, 839, 728, 339, 282, 444, 1338, 529, 1121, 682, 703560, 727, 576, 630, 703424, 381, 1123, 703385, 71, 583, 703386, 1154, 748, 278, 876, 478, 787, 477, 283, 997, 784, 1116, 703753, 1278, 703313, 703872, 1217, 258, 260, 259, 395, 433, 451, 1405, 703355, 703449, 703654, 703699, 703870, 256, 498, 703638, 703841, 704101, 704171, 1347, 1264, 703834, 704277, 704284, 704150, 703740, 703935, 703995, 703966, 703824, 703961, 1317, 704258, 430, 934, 492, 36, 1202, 833, 834, 1223, 364, 720, 490, 1008, 703845, 1165, 1089, 1330, 743, 271, 791, 370, 1175, 703438, 1150, 72, 844, 786, 1239, 230, 796, 257, 522, 523, 338, 1272, 764. 7. Model Number/System Code (UDI); Serial Numbers: 722221 (00884838099203); 108, 19, 153, 49, 115, 171, 6, 8, 127, 59, 56, 126, 106, 166, 155. 8. Model Number/System Code (UDI); Serial Numbers: 722222 (00884838099210); 55, 23, 44, 45, 187, 223, 99, 100, 101, 332, 51, 65, 11, 268, 188, 77, 80, 245, 109, 83, 50, 244, 177, 280, 13, 300, 5, 9. 9. Model Number/System Code (UDI); Serial Numbers: 722223 (00884838099241); 580, 669, 164, 127, 570, 131, 816, 365, 390, 352, 340, 242, 205, 627, 229, 262, 214, 458, 256, 728, 937, 944, 945, 951, 180, 439, 631, 681, 47, 126, 210, 336, 206, 367, 357, 572, 801, 197, 192, 87, 282, 177, 882, 208, 388, 581, 189, 479, 211, 186, 187, 566, 37, 370, 387, 116, 154, 99, 100, 598, 619, 854, 325, 787, 553, 185, 38, 859, 313, 314, 201, 1083, 860, 382, 645, 647, 646, 648, 30, 296, 297, 41, 914, 461, 808, 165, 33, 559, 563, 564, 558, 114, 176, 321, 661, 913, 246, 245, 422, 2, 639, 91, 333, 1056, 761, 21, 95, 531, 1017, 1037, 392, 358, 618, 590, 65, 295, 840, 12, 68, 465, 547, 702, 34, 450, 376, 451, 792, 876, 1077, 140, 988, 49, 442, 157, 539, 726, 342, 232, 492, 322, 591, 587, 812, 875, 904, 1167, 971, 532, 82, 109, 170, 4, 641, 640, 542, 543, 805, 121, 122, 374, 118, 13, 428, 983, 623, 1009, 515, 660, 712, 305, 179, 1007, 769, 754, 720, 721, 753, 755, 674, 344, 620, 768, 475, 474, 378, 294, 163, 815, 497, 362, 544, 707, 535, 536. 10. Model Number/System Code (UDI); Serial Numbers: 722224 (00884838099258); 606, 1828, 1829, 1830, 1201, 612, 503, 277, 261, 75, 182, 415, 876, 1488, 2957, 266, 512, 1160, 766, 2156, 2138, 250, 226, 360, 790, 452, 1147, 1278, 88, 1142, 792, 595, 892, 814, 813, 2995, 3120, 189, 2139, 2140, 108, 100, 591, 385, 260, 1827, 850, 338, 113, 438, 45, 444, 39, 554, 434, 3207, 696, 1499, 42, 841, 2656, 56, 2331, 421, 589, 2520, 793, 129, 84, 1810, 362, 327, 124, 125, 2280, 239, 1324, 950, 946, 381, 443, 252, 441, 621, 622, 435, 433, 99, 291, 332, 422, 1917, 2248, 2247, 2229, 2246, 1376, 1377, 1514, 351, 1960, 2045, 2403, 80, 183, 366, 101, 564, 396, 120, 454, 300, 1507, 1510, 329, 328, 1336, 307, 953, 1252, 1869, 1458, 904, 940, 1486, 165, 216, 527, 2376, 220, 176, 188, 466, 1112, 2913, 2426, 190, 490, 593, 469, 273, 333, 306, 432, 439, 244, 417, 414, 770, 516, 645, 1409, 565, 1625, 78, 267, 268, 789, 788, 478, 346, 298, 1299, 289, 1873, 2417, 1484, 1335, 1611, 657, 476, 251, 517, 507, 2018, 2239, 1555, 163, 240, 467, 468, 539, 128, 1126, 1246, 1259, 1255, 1256, 900, 191, 64, 1493, 1032, 2222, 1251, 1356, 194, 254, 1403, 440, 246, 2184, 2436, 613, 1565, 229, 286, 1508, 1461, 1512, 1511, 640, 1524, 836, 1692, 141, 574, 109, 2729, 46, 1063, 571, 174, 1490, 2569, 275, 262, 295, 272, 178, 228, 651, 462, 1049, 867, 1954, 1956, 116, 471, 233, 1995, 2185, 2860, 833, 874, 875, 1247, 1478, 330, 649, 173, 172, 379, 1477, 2752, 1672, 35, 1570, 406, 204, 206, 2081, 1042, 1591, 544, 2680, 1298, 513, 2349, 184, 2079, 545, 2080, 2082, 908, 573, 827, 1027, 1026, 1812, 781, 1204, 1184, 221, 208, 633, 3380, 816, 732, 647, 2510, 1388, 145, 2534, 2527, 2124, 1325, 2638, 632, 1766, 2214, 2269, 2575, 1169, 2515, 2337, 2338, 2823, 2825, 1539, 463, 368, 2415, 383, 563, 519, 1686, 2089, 2574, 1367, 988, 2163, 2725, 2724, 93, 1671, 1594, 1595, 2568, 1401, 2851, 1092, 534, 86, 1572, 634, 782, 1406, 3223, 19, 2230, 2480, 1962, 2218, 227, 337, 822, 1981, 1953, 1864, 749, 1952, 382, 4, 37, 1778, 3135, 648, 971, 2983, 861, 2482, 31, 1523, 59, 898, 866, 2730, 52, 29, 853, 810, 1722, 724, 1431, 171, 413, 2310, 2804, 596, 1737, 801, 937, 1326, 1330, 1349, 1350, 1369, 1609, 2244, 2245, 2373, 3099, 731, 1505, 1552, 280, 764, 1065, 910, 142, 1421, 721, 1430, 2068, 654, 397, 557, 1188, 2134, 2424, 1814, 2101, 2103, 2618, 2343, 2260, 2259, 2261, 2267, 2706, 2707, 2714, 2758, 2813, 3288, 2812, 2828, 1800, 1799, 2263, 2300, 2299, 2705, 2745, 2704, 2819, 2905, 2788, 2817, 2889, 3287, 3286, 3295, 1815, 2102, 2105, 2749, 2751, 1930, 2715, 1139, 156, 1562, 803, 671, 1538, 1730, 387, 13, 399, 2151, 424, 16, 2007, 3, 1331, 7, 863, 8, 358, 3259, 658, 1051, 1050, 1052, 1053, 1054, 1080, 1348, 2277, 604, 3271, 542, 729, 203, 1728, 1736, 610, 2344, 48, 635, 2848, 1272, 2402, 799, 800, 85, 2050, 537, 1566, 1588, 1656, 1649, 1447, 2046, 1602, 2013, 18, 1536, 1580, 1387, 1433, 1957, 1678, 2011, 2076, 2099, 1703, 1933, 1837, 2275, 1196, 1391, 1393, 1404, 1402, 2916, 1645, 1854, 1359, 1443, 1587, 1392, 1399, 1422, 1677, 1691, 1710, 2009, 1345, 2014, 1600, 1620, 2028, 2071, 1425, 1340, 1333, 1855, 2153, 1585, 1372, 1408, 1432, 2049, 1586, 2055, 1429, 1535, 1537, 1544, 1543, 1865, 1597, 1398, 1462, 1596, 1603, 1598, 1327, 2056, 2175, 2330, 1968, 1936, 1351, 2016, 1980, 1495, 2002, 2087, 1666, 1584, 2069, 2398, 1806, 1969, 1601, 1621, 1589, 1699, 1734, 1758, 2305, 2339, 1835, 1583, 1868, 1805, 1644, 2021, 2104, 727, 2057, 213, 509, 1932, 2621, 3263, 984, 344, 829, 1590, 2017, 1522. 11. Model Number/System Code (UDI); Serial Numbers: 722225 (00884838099265); 259, 55, 268, 147, 340, 72, 71, 216, 299, 291, 289, 249, 110, 298, 46, 29, 122, 233, 157, 149, 237, 167, 364, 4, 398, 30, 231, 38, 219, 170, 171, 90, 89, 77, 369, 161, 163, 137, 162, 40, 91, 74, 125, 190, 303, 377, 211, 329, 280, 86, 8, 31, 384, 87, 283, 421, 422, 267, 241. 12.Model Number/System Code (UDI); Serial Numbers: 722226 (00884838099272); 219, 120, 272, 105, 144, 319, 204, 255, 153, 350, 442, 183, 78, 467, 108, 143, 360, 555, 114, 209, 174, 687, 281, 554, 181, 147, 379, 468, 173, 271, 182, 419, 472, 122, 123, 124, 125, 126, 127, 403, 294, 194, 249, 432, 892, 87, 790, 261, 514, 766, 941, 228, 539, 950, 489, 622, 628, 637, 491, 345, 625, 93, 238, 299, 166, 364, 5, 506, 557, 227, 188, 827, 453, 883, 171, 708, 738, 655, 382, 106, 56, 196, 236, 770, 73, 302, 402, 210, 304, 916, 904, 40, 525, 653, 157, 657, 583, 540, 216, 456, 357, 596, 733, 439, 118, 263, 24, 840, 88, 224, 231, 233, 407, 598, 21, 762, 882, 505, 542, 507, 497, 485, 490, 494, 643, 644, 543, 636, 849, 633, 634, 504, 550, 551, 484, 631, 316, 639, 640, 642, 563, 547, 591, 911, 277, 278, 207, 773, 832, 501, 1000, 810. 13. Model Number/System Code (UDI); Serial Numbers: 722227 (00884838099227); 88, 135, 261, 19, 133, 134, 241, 164, 82, 32, 16, 12, 72, 64, 242, 176, 2, 75, 145, 143, 120, 112, 74, 188, 147, 146, 77, 141, 234, 14, 15, 47, 95, 163, 48, 3, 1, 123, 92, 173, 174, 121, 204, 57, 282, 8, 9. 14. Model Number/System Code (UDI); Serial Numbers: 722228 (00884838099234); 187, 328, 113, 205, 204, 150, 159, 23, 127, 24, 10, 36, 6, 213, 64, 20, 26, 47, 149, 62, 502, 18, 125, 391, 395, 229, 12, 408, 309, 310, 557, 98, 261, 179, 536, 143, 46, 70, 7, 13, 191, 259, 218, 11, 223, 370, 389, 14, 71, 39, 465, 552. 15. Model Number/System Code (UDI); Serial Numbers: 722282 ((01)00884838110571(21)8); 8.

Quantity Affected: 1,861 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-08-01

Company