Class II FDA device recall · Z-2503-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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.

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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 record

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type: Devices
Recall number: Z-2503-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Best, N/A
Recall initiated: 2025-08-01

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2503-2025 · Source: openFDA enforcement.