Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-2502-2025

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Sep 10, 2025 · 10 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 information

Model
System Code (
Serial #
722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 120, 153, 96, 108. 2
Model
System Code (
Serial #
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
System Code (
Serial #
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
System Code (
Serial #
722068 (00884838085367); 213, 111, 85, 89, 320, 73 — +59 moreShow all
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
System Code (
Serial #
722078 (00884838085251); 465, 143, 278, 402, 290, 524 — +188 moreShow all
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
Show 20 more code fields
Model
System Code (
Serial #
722079 (00884838085268); 942, 948, 702, 703465, 1316, 1042 — +347 moreShow all
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
System Code (
Serial #
722221 (00884838099203); 108, 19, 153, 49, 115, 171, 6, 8, 127, 59, 56, 126, 106, 166, 155. 8
Model
System Code (
Serial #
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
System Code (
Serial #
722223 (00884838099241); 580, 669, 164, 127, 570, 131 — +188 moreShow all
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
System Code (
Serial #
722224 (00884838099258); 606, 1828, 1829, 1830, 1201, 612 — +610 moreShow all
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
System Code (
Serial #
722225 (00884838099265); 259, 55, 268, 147, 340, 72 — +53 moreShow all
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
System Code (
Serial #
722226 (00884838099272); 219, 120, 272, 105, 144, 319 — +146 moreShow all
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
System Code (
Serial #
722227 (00884838099227); 88, 135, 261, 19, 133, 134 — +41 moreShow all
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
System Code (
Serial #
722228 (00884838099234); 187, 328, 113, 205, 204, 150 — +46 moreShow all
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
System Code (
Serial #
722282 ((01)00884838110571(21)8); 8

What the firm is doing

Philips notified consignees on about 08/01/2025 via letter. Consignees were informed that systems may still be utilized in accordance with their Instructions for Use (IFU), notify all applicable personnel of this recall, maintain the Urgent Medical Device Correction letter with documentation of the system until Philips corrects the system, and establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. If an affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. Additionally, consignees were requested to complete and return the provided response form and report any issue experienced to Philips.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls