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Azurion recallZ-2502-2025 · Philips Medical Systems Nederland B.V. · initiated Aug 1, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company 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.

Recall details

Recall number
Z-2502-2025
Status
Open, Classified
Initiated by the company
Aug 1, 2025
Posted by the FDA
Sep 3, 2025
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
1,861 units
Product code
OWB
FDA submissions
K172822, K181830, K200917
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.

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.

Code information (models, lots, serial numbers)

Show the full code information (11k characters)

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.

Devices named in this recall

14 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97249).

Sources and updates

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