FDA event 97502 · Recall Observatory

device · product 1 of 15

Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0001-2026

Recall number: Z-0001-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 2 units (US only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Number: 722003; UDI-DI: N/A; Serial Numbers: 19, 21;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 2 of 15

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0002-2026

Recall number: Z-0002-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 2317 units (497 US, 1820 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) N/A, (2) 00884838059030, (3) 00884838054189; Serial Numbers: (1) 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959, 1138, 490, 1188, 1532, 940, 1214, 401, 1627, 1031, 1728, 1189, 285, 1311, 1700, 998, 1187, 1222, 305, 1353, 939, 1326, 445, 1223, 700, 657, 527, 1634, 1023, 917, 1043, 994, 995, 945, 521, 590, 591, 855, 491, 1615, 1732, 1761, 1078, 367, 690, 1529, 385, 997616, 1085, 1663, 653, 1667, 928, 1449, 968, 1286, 72, 1622, 1621, 472, 1799, 463, 619915, 696, 1525, 1514, 574, 306, 1114, 1584, 447, 1950, 1647, 406, 1555, 1482, 1489, 1443, 1444, 1072, 1954, 1704, 1232, 749, 1266, 1089, 259, 1259, 1787, 345, 640, 37, 1714, 546, 1133, 1135, 1032, 1512, 892, 684, 857, 1084, 1067, 2936, 1411, 947, 197, 392, 1271, 1807, 1805, 1575, 963, 1430, 8198, 1869, 1594, 467, 1551, 1947, 390, 342, 368, 912, 913, 8091, 1471, 1474, 1446, 1001, 1092, 1718, 1637, 453, 833, 430, 1738, 1749, 1491, 1605, 1130, 5, 639, 674, 797, 1033, 1357, 1632, 1744, 281, 391, 1535, 350, 452, 629, 732, 754, 1038, 1045, 1536, 1056, 599, 1331, 756, 1351, 1611, 1610, 1804, 1122, 1413, 644, 545, 1059, 1327, 513, 1163, 1204, 1193, 1549, 418, 1778, 955, 1199, 2933, 517, 1597, 1585, 1063, 1596, 1341, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 319, 411, 412, 413, 414, 415, 1395, 1338, 1706, 1572, 1916, 1282, 789, 790, 614, 763, 728, 605, 622, 492, 1612, 192, 1613, 1648, 1568, 1569, 1570, 1685, 1314, 948, 505, 566, 1297, 895619, 1108, 1277, 239, 1216, 328, 1492, 863, 1616, 370, 359, 388, 1169, 1118, 1416, 1260, 1609, 115, 1337, 1107, 519, 1155, 13, 1478, 1090, 1662, 1818, 1094, 1142, 1730, 1463, 1752, 1215, 1558, 1578, 1083, 1378, 985, 1014, 1231, 356, 310, 777, 307, 308, 309, 778, 780, 1127, 1167, 1186, 742, 1653, 1051, 898, 1689, 715, 716, 423, 1571, 1101, CV.615, 1399, 1931, 1149, 753, 377, 1255, 424, 1733, 606, 1247, 1293, 548, 813, 1524, 1457, 321, 1421, 1979, 1487, 249, 1509, 937, 1016, 1857, 676, 875, 373, 313, 314, 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1350, 971, 1345, 356, 877, 164, 1125, 272, 989, 340, 35, 34, 249, 1196, 1294, 114, 80, 1445, 380, 1276, 1200, 935, 1242, 224, 106, 104, 103, 1401, 622, 371, 162, 333, 927, 1022, 1000, 930, 1197, 1116, 903, 1435, 91, 1346, 602, 245, 535, 230, 231, 232, 991, 248, 1111, 742, 1029, 222, 797, 254, 416, 1010, 957, 92, 687, 1304, 187, 502, 1124, 174, 537, 1199, 941, 553, 1339, 1001, 1351, 1307, 173, 134, 1137, 282, 483, 847, 1068, 760, 1008, 1213, 1092, 1151, 1083, 1268, 955, 711, 1145, 514, 1273, 66, 1157, 1119, 702, 860, 1446, 685, 686, 942, 181, 357, 1190, 961, 287, 948, 509, 619, 185, 1104, 887, 394, 304, 863, 799, 1224, 1225, 1021, 1422, 1033, 1136, 998, 733, 154, 834, 1150, 1091, 832, 311, 142, 388, 1451, 599, 1188, 235, 236, 1031, 1030, 850, 250, 1097, 904, 199, 328, 182, 294, 1066, 77, 122, 810, 184, 474, 471, 962, 771, 138, 1182, 549, 1065, 1376, 1433, 1355, 689, 163, 631, 1303, 1155, 558, 804, 1044, 822, 852, 880, 476, 862, 1280, 1300, 1077, 858, 362, 1207, 1076, 874, 1218, 1130, 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1023, 456, 199, 784, 216, 900, 315, 1004, 255, 887, 886, 1102, 1002, 107, 308, 414, 1058, 896, 366, 710, 524, 290, 1151, 706, 532, 443, 442, 547, 417, 1357, 38, 870, 1365, 889, 412, 862, 1369, 398, 1090, 305, 163, 411, 466, 105, 1273, 788, 419, 1035, 170, 384, 1344, 1345, 247, 481, 827, 212, 318, 316, 317, 1030, 1178, 1131, 675, 1358, 256, 336, 1322, 623, 1130, 1172, 892, 588, 291, 1257, 743, 408, 286, 1H071046, 1162, 70, 1323, 1325, 260, 106, 83, 876, 211, 655, 568, 198, 268, 495, 974, 793, 160, 907, 486, 1251, 469, 669;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 3 of 15

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0003-2026

Recall number: Z-0003-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 585 units (145 US, 440 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51, 367, 348, 160, 271, 530, 112, 70, 520, 323, 49, 329, 365, 269, 270, 523, 490, 346, 129, 258, 298, 316, 485, 261, 169, 427, 352, 474, 497, 251, 100, 456, 360, 305, 419, 405, 489, 306, 307, 467, 234, 333, 533, 209, 369, 543, 332, 328, 366, 339, 389, 538, 394, 378, 379, 237, 165, 2724, 238, 415, 473, 482, 397, 53, 385, 52, 447, 96, 429, 159, 531, 58, 499, 229, 374, 25, 354, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 561, 511, 478, 428, 500, 464, 463, 14, 459, 416, 359, 487, 564, 469, 72, 125, 494, 76, (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 79, 76, 17, 87, 255, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 189, 186, 118, 119, 300, 213, 372, 12, 55, 41, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 75, 307, 301, 18, 302, 303, 304, 305, 306, 293, 294, 184, 266, 146, 116, 68, 310, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 141, 139, 77, 99, 277, 313, 223, 27, 26, 29, 340, 69, 374, 328, 228, 251, 231, 323, 224, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 86, 378, 376, 377, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 104, 290, 244, 333, 287, 38, 39, 176, 282, 216, 158, 329, 246, 295, 56, 337, 292, 125, (3) 203, 335, 123, 133, 134, 284, 280, 183, 169, 106, 107, 234, 42, 101, 307, 265, 306, 267, 209, 153, 40, 332, 156, 112, 305, 1, 104, 263, 342, 71, 255, 351, 298, 175, 120, 116, 174, 241, 240, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 293, 292, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 338, 334, 162, 273, 5, 160, 246, 61, 36, 299, 294, 345, 76, 94, 350, 348, 349, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 126, 81, 268, 356, 244, 221, 55, 86, 254, 6, 117, 113, 362, 271, 186, 259, 236, 201, 275, 135, 277, 3, 58, 249, 149, 148, 38, 47, 316, 27, 165, 274, 80, 64, 205, 223, 270, 181, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 214, 145, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 243, 242, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 23, 24, 21, 20, 65;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 4 of 15

Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0004-2026

Recall number: Z-0004-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 2 units (1 US, 1 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722033; UDI-DI: 00884838059078 Serial Numbers: 1, 6;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 5 of 15

Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0005-2026

Recall number: Z-0005-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 5067 units (1626 US, 3441 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722006, (2) 722012, (3) 722028; UDI-DI: (1) N/A, (2) 00884838059054, (3) 00884838054202; Serial Numbers: (1) 535, 2522, 1364, 2268, 172, 415, 2324, 1637, 2533, 1881, 2158, 1774, 468, 1477, 265, 2051, 2462, 43074, 1352, 771, 1734, 272, 1589, 1445, 1547, 929, 2122, 1414, 207, 135, 731, 2131, 443, 2569, 914, 2097, 1890, 2281, 1896, 1762, 1764, 167, 159, 774, 1242, 168, 2198, 2009, 1629, 810, 1211, 2454, 1646, 1209, 1924, 1339, 637, 2301, 213, 1927, 1928, 1706, 2570, 2571, 1582, 972, 878, 2200, 331, 1575, 707, 1761, 861, 2537, 469, 718, 722, 553, 301, 225, 498, 72246F, 1457, 1730, 1936, 1274, 1490, 2045, 1338, 1659, 2610, 920, 1662, 504, 1346, 308, 529, 1587, 2013, 2155, 1977, 2140, 664, 1843, 1594, 534, 1875, 637220, CV.381, 886, 1139, 2267, 1583, 1585, 1520, 2126, 1856, S01H006016/000001, 691, 1941, 288, 702, 2390, 1425, 1496, 862, 204, 2366, 2456, 2269, 679, 2425, 2066, 1744, 1747, 1812, 2606, 641, 268, 1728, 285, 559, 149, 1443, 2530, 283, 1755, 1439, 1120, 889, 518, 852, 853, 2062, 1007, 1104, 1473, 2110, 121, 1237, 186, 1914, 550, 1752, 2565, 893, 2347, 120, 848, 904, 1754, 269, 1696, 843, 1227, 2021, 425, 1239, 1302, 343, 2195, 1723, 767, 366, 436, 1523, 435, 1733, 333, 1978, 1206, 211, 2102, 1588, 826, 782, 1177, 1293, 587, 1391, 161, 1956, 187, 638, 1387, 953, 1201, 1363, 2027, 1601, 2561, 2256, 2070, 314, 2002, 1627, 2548, 2587, 2427, 588, 1865, 2152, 1046, 1361, 2430, 2028, 1711, 2003, 1564, 1370, 1534, 1987, 2054, 2283, 1888, 1854, 1407, 221, 494, 2607, 1641, 1366, 1604, 655, 1169, 1114, 1115, 1116, 1127, 1H041985, 723, 18268, 1085, 2112, 2106, 2111, 1536, 1732, 1870, 1420, 1818, 1341, 1827, 521, 849, 1550, 1359, 913, 674, 1720, 1476, 1766, 1446, 1908, 2326, 1118, 616, 828, 2525, 822, 1306, 1289, 595, 1729, 830, 298, 2296, 705, 1932, 1935, 234, 780, 1273, 384, 1502, 2201, 804, 1727, 1900, 1092, 2088, 1480, 388, 378, 1168, 1631, 1260, 1207, 2007, 1831, 730, 2187, 797, 1328, 1922, 1107, 24, 1380, 95, 1844, 1848, 1611, 683, 968, 2143, 1235, 1323, 778, 1081, 1466, 2336, 606, 327, 1469, 1830, 1256, 1832, 1600, 775, 1654, 1707, 1147, 860, 2459, 2297, 753, 1639, 376, 800, 1615, 1833, 992, 1612, 1939, 2184, 1807, 661, 1872, 2042, 2181, 1448, 1868, 1955, 1740, CV.514, 184, 888, 2380, 2272, S4F621389A000001, 315, 1050, 1511, 2147, 90, 1942, 1095, 1096, 2382, 1276, 1845, 1441, 1438, 1351, 658, 1518, 2250, 1780, 1326, 1259, 1913, 1185, 1731, 1000, 1653, 2203, 1221, 680, 2199, 1609, 599, 1921, 2135, 1886, 1889, 166, 2183, 1433, CV.643, 2025, 1911, 287, 141, 612, 1648, 1174, 1507, 1229, 2323, 1318, 1093, 471, 1750, 2564, 1560, 781, 2058, 1710, 2612, 2161, 1277, 1603, 1790, CV.740, 1621, 1640, 1670, 2159, 1578, 1906, 602A, 1383, 2412, 2274, 1373, 1983, 2286, 1100, 1270, 1591, 2318, 1022, 1838, 1125, 1089, 511, 1307, 833, 1712, 1198, 812, 2392, 594, 794, 1741, 990, 1481, 1349, 1454, 1455, 1456, 1751, 2053, 1917, 2240, 1667, 2038, 1460, 1401, 1965, 951, 1819, 902, 492, 2104, 2348, 2423, 1925, 1552, 1999, 1704, 2488, 1117, 1963, 1295, 2247, 1424, 717, 2137, 2278, 1222, 1253, 1947, 2293, 2124, 1687, 1129, 1337, 2529, 1791, 8, 2584, 2049, 808, 1158, 590, 1255, 2043, 1350, 1213, 994, 2173, 1859, 2304, 666, 2520, 2086, 1692, 2475, 1264, 1524, 740, 1402, 941, 958, 2531, 2046, 2371, 1468, 1801, 2465, 2514, 768, 1316, 1075, 2551, 2368, 1991, 1193, 1605, 2145, 2176, 1753, 1851, 578, 1708, 2175, 2129, 1317, 1180, 1517, 2580, 687, 1652, 2154, 1203, 2342, 1557, 2550, 1884, 100079164-1971, 1580, 600, 1464, 2373, 2031, 1504, 1440, 491, 2179, 1784, 2061, 2538, 2428, 1602, 1542, NL94, 2214, 971, 1997, 1824, 859, 1021, 1802, 2085, 2103, 1452, 1808, 1533, 820, 63, 2023, 2182, 2343, 2206, 2411, 1246, 1003, 1509, 2232, 659, 2217, 2526, 614, 2015, 609, 1969, 2194, 2553, 880, 2555, 922, 1598, 2034, 1773, 689, 2114, 1494, 819, 2040, 2069, 2171, 1062, 1759, 585, 2219, 2228, 2259, 2063, 2391, 1823, 2150, 608, 1554, 1916, 2279, 1233, 1793, 1919, 2399, 854, 2039, 1513, 1817, 1505, 2288, 1347, 2292, 867, 1948, 2434, 1200, 1892, 1130, 1617, 955, 2144, 1344, 1988, 2064, 1284, 1529, 1814, 1515, 1815, 1463, 2244, 1891, 2305, 1336, 1004, 1106, 1787, 946, 952, 482, 1763, 1985, 1899, 1777, 1968, 2438, 1650, 887, 1992, 2094, 811, 2041, 1538, 1840, 2360, 2325, 837, 856, 2022, 2369, 1537, 1893, 2115, 1715, 925, 2101, 1998, 2109, 1714, 2245, 1961, 2314, 1651, 2291, 1880, 1561, 873, 1746, 2080, 2255, 2307, 2162, 1530, 2095, 1232, 1343, 1506, 2192, 2093, 1348, 1678, 704, 1849, 2361, 1595, 164, 1423, 1492, 565, 2243, 1568, 2248, 2552, 2117, 1397, 1618, 1224, 636, 1949, 1403, 1192, 2419, 891, 2004, 1204, 1967, 885, 2010, 374, 1794, 2231, 1876, 1686, 2393, 2334, 1858, 2225, 1392, 1149, 940, 931, 2310, 696, 1658, 151, 963, 2517, 1749, 2275, 1408, 2353, 1551, 486, 549, 2067, 2163, 1668, 2547, 1525, 2237, 1031, 2230, 688, 831, 1690, 1250, 520, 2166, 1738, 1281, 1488, 2290, 617, 1056, 2165, 1952, 2375, 1540, 602, 2493, 640, (2) 1117, 1001, 1673, 1712, 585, 2876, 1545, 70, 1715, 757, 935, 1356, 1250, 2006, 1613, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 494, 335, 1804, 100, 1408, 276, 595, 590, 2302, 2508, 2511, 2509, 1279, 452, 2151, 1724, 2901, 2134, 348, 893, 1187, 2085, 1455, 2202, 423, 1282, 718, 325, 2723, 2697, 2721, 2726, 2722, 796, 2890, 525, 2307, 1798, 1656, 399, 990, 2693, 1806, 1871, 2506, 2518, 243, 1652, 2883, 894, 2920, 1189, 1099, 1038, 1058, 823, 1037, 72, 924, 2319, 2310, 2713, 1610, 686, 2933, 2514, 1108, 2829, 1294, 568, 2886, 2760, 1077, 440, 1422, 1537, 2888, 2875, 1035, 285, 84, 1317, 1649, 1895, 1900, 1723, 2353, 878, 919, 1581, 2221, 2496, 2311, 2222, 1515, 2828, 1803, 2484, 1731, 1017, 1020, 380, 1811, 527, 2171, 782, 418, 1053, 1558, 1336, 1014, 601, 1265, 751, 1324, 2276, 732, 389, 2086, 1285, 2219, 2687, 298, 814, 815, 1120, 278, 1713, 1506, 1098, 580, 1852, 1307, 1858, 377, 758, 610, 1598, 2912, 172, 2054, 856, 1690, 1407, 690, 1327, 695, 2896, 1207, 1036, 2740, 733, 1254, 1091, 797, 735, 1280, 2138, 828, 2821, 1118, 740, 1249, 542, 1033, 2265, 2951, 961, 2935, 490, 302, 920, 1209, 470, 1075, 2203, 2774, 1396, 606, 444, 66, 2092, 2892, 597, 1269, 67, 1002, 244, 1022, 1023, 2264, 2234, 1805, 1192, 1823, 615, 483, 484, 2150, 2899, 892, 1478, 1262, 1688, 1961, 1732, 1062, 650, 649, 767, 2657, 1104, 1641, 1277, 2609, 1975, 316, 1335, 1461, 959, 159, 489, 766, 639, 669, 671, 1583, 625, 2692, 651, 1047, 107, 1447, 99, 676, 124, 1616, 1660, 1083, 1924, 1807, 511, 1714, 101, 75, 1406, 352, 492, 643, 1270, 577, 578, 1306, 855, 1456, 2269, 1078, 71, 768, 2285, 1793, 1797, 1216, 948, 387, 498, 1570, 2521, 1662, 104, 1868, 2313, 1743, 369, 2942, 2516, 1561, 1692, 2286, 2293, 1960, 1508, 616, 1084, 2289, 655, 1796, 1026, 2629, 1337, 685, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 531, 1586, 1617, 1904, 1918, 1354, 1906, 160, 383, 560, 68, 2755, 2614, 114, 1948, 1195, 518, 888, 1329, 1992, 792, 323, 1003, 1219, 2898, 89, 115, 2004, 2003, 2835, 2843, 135, 174, 1832, 2133, 2166, 562, 1941, 859, 760, 1593, 1608, 731, 1328, 848, 2656, 2292, 1946, 274, 1063, 1587, 2308, 1271, 613, 1842, 205, 2736, 1799, 1665, 187, 1513, 2889, 2869, 2868, 2015, 2207, 2842, 2841, 2840, 2849, 2309, 2161, 1116, 691, 1993, 943, 2873, 150, 1281, 1945, 1919, 337, 110, 1735, 1326, 788, 488, 1218, 132, 1519, 1533, 336, 2013, 1334, 1405, 1141, 925, 923, 406, 2741, 1293, 513, 2712, 1446, 1625, 1675, 1683, 1148, 1181, 2515, 207, 442, 1305, 499, 1716, 1726, 85, 476, 1657, 1045, 1531, 1630, 2610, 851, 1827, 277, 1923, 2677, 1516, 404, 453, 321, 334, 197, 2857, 1869, 2215, 574, 1611, 2874, 1559, 2924, 1686, 2855, 2856, 858, 1224, 1345, 86, 2057, 1430, 2696, 1255, 1599, 1989, 2844, 666, 2014, 2022, 1126, 1943, 1549, 1188, 1073, 1404, 1664, 103, 2063, 533, 1947, 1950, 1467, 1596, 2607, 326, 926, 675, 756, 424, 1027, 1894, 2148, 2146, 2145, 234, 2065, 1527, 1477, 2227, 2900, 1177, 1645, 2522, 2735, 2156, 93, 1167, 1595, 2469, 88, 1672, 1210, 1512, 1101, 787, 1399, 123, 136, 126, 2658, 1119, 2655, 954, 952, 953, 1661, 2707, 570, 1622, 1115, 1316, 1212, 1032, 976, 1746, 986, 971, 1594, 233, 640, 446, 2929, 2081, 69, 1301, 2254, 2323, 1542, 430, 1607, 76, 2454, 2149, 1211, 1004, 2046, 974, 2305, 1044, 2881, 505, 2937, 310, 192, 314, 852, 2930, 1016, 224, 2645, 2653, 1097, 1532, 1964, 2135, 1357, 589, 1092, 248, 846, 963, 964, 1658, 412, 1344, 1260, 2108, 1655, 1433, 1132, 1909, 1361, 333, 1492, 1815, 2047, 837, 922, 1681, 2282, 1333, 1504, 328, 781, 774, 1902, 2249, 1708, 674, 1495, 2287, 1244, 140, 2891, 482, 1363, 2438, 2466, 2517, 1696, 1448, 678, 546, 1453, 510, 806, 1289, 2764, 2294, 1046, 1973, 2637, 994, 1284, 1145, 1144, 223, 1081, 1966, 2676, 2630, 1436, 780, 2502, 632, 863, 2297, 726, 1700, 2880, 1853, 2089, 2045, 2575, 246, 1171, 1341, 2098, 1292, 2666, 2476, 545, 1972, 1391, 271, 2380, 966, 125, 432, 2626, 1640, 2568, 1667, 1157, 1921, 1579, 1248, 2838, 1623, 1290, 1702, 916, 2316, 2887, 2444, 1637, 1082, 762, 2112, 1576, 2123, 769, 329, 119, 2679, 2567, 2118, 2919, 2030, 98, 1297, 2103, 1147, 1303, 211, 2703, 2690, 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1489, 1166, 2734, 1127, 2345, 2849, 1832, 2368, 507, 508, 1728, 1490, 2113, 2655, 1163, 2473, 2349, 2528, 1588, 2723, 2318, 1107, 2091, 2327, 2332, 988, 2221, 1316, 1732, 2719, 2669, 915, 1662, 2792, 2763, 948, 2649, 2940, 2858, 186, 1970, 1496, 1026, 1973, 2487, 2229, 1252, 2515, 2242, 1324, 2063, 2741, 487, 2624, 2591, 2213, 1900, 1753, 2296, 2910, 1376, 2051, 2736, 1805, 2619, 2616, 2120, 1745, 2183, 2560, 2518, 2129, 2767, 1410, 2216, 876, 2535, 2626, 1747, 2339, 2036, 2100, 1431, 2771, 2044, 2405, 1647, 736, 737, 735, 2631, 2680, 2643, 1470, 2804, 2271, 1537, 2784, 2459, 2832, 2892, 2193, 2803, 1497, 2227, 1581, 1208, 2130, 2712, 2777, 2477, 2476, 2661, 1987, 1892, 2860, 2018, 2127, 2223, 1194, 2656, 2064, 1760, 2780, 1298, 1564, 1589, 2279, 2822, 2188, 2881, 2042, 2556, 1806, 2366, 1055, 2367, 2627, 2696, 1474, 1096, 2387, 2536, 1336, 2896, 2685, 2359, 2363, 2565, 2516, 1561, 2717, 2032, 1057, 2125, 2863, 2464, 2931, 1770, 1048, 848, 2072, 2845, 1885, 2137, 2201, 2744, 1167, 2521, 1512, 1777, 2644, 2369, 2432, 2358, 2693, 2542, 2147, 2031, 1531, 2816, 2210, 2566, 2396, 1106, 1767, 1121, 1941, 2159, 2287, 2323, 2756, 1790, 2783, 2162, 1377, 1681, 1780, 2812, 1289, 2894, 1906, 2705, 1936, 2517, 2660, 2504, 2592, 2505, 2166, 2441, 1131, 2942, 2865, 2428, 2040, 2600, 2094, 1969, 2571, 1974, 2389, 2552, 2300, 2131, 2411, 2882, 1804, 1674, 1245, 2950, 2886, 2219, 1867, 2684, 1711, 2439, 2254, 1696, 2947, 2795, 2557, 2730, 2512, 2138, 2393, 1536, 2257, 1541, 1240, 1939, 1402, 815, 1990, 2757, 2793, 1138, 1801, 2167, 2392, 1229, 2442, 2728, 1903, 2265, 2836, 2234, 1882, 2285, 2880, 1803, 2796, 2397, 2114, 2297, 2856, 1916, 2068, 2738, 2588, 2737, 1998, 1764, 831, 1217, 2436, 936, 2613, 2458, 2346, 2409, 1778, 2802, 2904, 2567, 2465, 2775, 2670, 1455, 1921, 2488, 1468, 1871, 1091, 2161, 2468, 2075, 2182, 2715, 2165, 2333, 2735, 2023, 1360, 2228, 1908, 1196, 1752, 1478, 2509, 2370, 1427, 2214, 2731, 2303, 1962, 2523, 2184, 2628, 2027, 2175, 2956, 2606, 2749, 1250, 1942, 2868, 2941, 2888, 1899, 2648, 2069, 2762, 2794, 2633, 2283, 2454, 1862, 1574, 2301, 2857, 2146, 2117, 1929, 2092, 2208, 2679, 1876, 907, 2634, 1664, 2691, 2704, 2378, 2847, 1599, 2148, 2930, 2854, 2492, 1765, 1739, 2742, 2651, 1725, 2607, 2022, 2203, 1290, 2586, 2776, 2899, 2142, 2549, 2913, 503, 162, 2457, 2202, 2440, 2574, 2748, 1935, 2185, 1415, 1683, 1912, 2688, 2687, 2872, 2288, 2141, 2640, 1542, 2593, 2486, 1991, 2264, 1528, 1744, 2164, 2326, 2844, 2835, 2325, 1594, 2469, 2420, 2419, 1888, 2453, 2914, 2309, 1976, 2497, 1192, 2564, 2548, 2584, 2291, 1905, 2870, 2650, 2282, 2841, 2154, 1742, 2251, 2329, 2321, 2629, 1185, 1796, 2394, 943, 1793, 2903, 2902, 2014, 2343, 2013, 2498, 1678, 796, 1161, 2381, 2909, 2773, 1504, 2109, 2128, 2307, 2499, 2786, 1090, 2785, 2526, 2733, 2096, 1910, 2923, 2769, 2878, 1841, 1643, 2052, 1944, 2937, 2406, 1727, 2750, 2337, 1465, 2382, 2313, 2209, 2768, 2754, 1923, 2766, 1216, 2596, 1642, 1573, 2462, 1575, 2160, 1761, 2540, 1680, 755, 1665, 715, 2448, 1530, 2494, 2530, 1965, 2554, 2597, 1904, 2599, 2782, 2781, 2116, 1552, 1469, 2524, 1019, 2611, 2118, 2365, 1473, 1544, 1253, 1808, 1543, 1963, 2360, 2943, 2531, 1153, 2864, 2925, 1795, 2852, 2412, 1933, 2067, 1762, 1738, 2561, 1958, 1355, 1593, 2341, 1223, 2260, 1158, 2722, 1661, 1849, 2119, 1663, 1521, 2800, 1847, 2449, 2829, 2395, 2595, 2746, 1375, 1464, 2270, 1992, 2230, 2232, 2580, 999, 1518, 2740, 1997, 2225, 2683, 2136, 2871, 2399, 1981, 2919, 1773, 1659, 1401, 2884, 1409, 2801, 2866, 1276, 2890, 2686, 2272, 2437, 2739, 2474, 2278, 2062, 2808, 2268, 1510, 2156, 2908, 2817, 2263, 2543, 2948, 2653, 2875, 1961, 2520, 2003, 1943, 1251, 2525, 2452, 2401, 2932, 2787, 1502, 2828, 2144, 2848, 2331, 2011, 1653, 2689, 1954, 1763, 1697, 1162, 1398, 2582, 1746, 2289, 2508, 2630, 2269, 2861, 1671, 1670, 2226, 2308, 1227, 2431, 2678, 2544, 2299, 624, 2716, 2944, 2563, 1668, 2807, 337, 2869, 1443, 2471, 690, 1097, 797, 747, 845, 844, 846, 573, 1720, 1258, 802, 104, 1555, 1292, 817, 778, 764, 369, 2667, 1302, 2078, 2380, 150, 941, 380, 2830, 1044, 1451, 320, 2102, 353, 1159, 1025, 762, 1638, 839, 1645, 814, 1088, 63, 116, 1312, 2207, 1403, 484, 2632, 1134, 1135, 1359, 1802, 2485, 1342, 2938, 1535, 2900, 2529, 1146, 639, 1703, 179, 2077, 398, 2495, 1539, 2390, 1206, 1986, 1438, 1087, 1086, 851, 2770, 1937, 9, 2831, 105, 111, 2076, 951, 2035, 2256, 2519, 1816, 1817, 652, 467, 2169, 1945, 1818, 2104, 926, 709, 440, 2398, 823, 1532, 822, 2445, 2163, 1184, 2726, 392, 2037, 1442, 1596, 568, 2410, 1972, 2772, 2450, 1123, 1124, 2809, 101, 2353, 1879, 1977, 2692, 107, 124, 225, 1660, 1891, 1968, 1654, 113, 832, 415, 727, 387, 2108, 2743, 1851, 608, 1554, 576, 577, 30, 1105, 1346, 1309, 716, 14, 726, 723, 722, 2585, 1361, 613, 1689, 1792, 191, 1209, 1500, 299, 298, 300, 1221, 1884, 1825, 2546, 2503, 2681, 2853, 2236, 1913, 2238, 1064, 1320, 2895, 2840, 2928, 1960, 2472, 2879, 2015, 1595, 1768, 1901, 1692, 662, 650, 175, 2357, 2356, 1073, 1839, 2274, 1602, 1390, 1372, 702, 834, 606, 1045, 2101, 1037, 557, 593, 594, 301, 732, 98, 156, 1548, 2598, 1426, 919, 2620, 2467, 1265, 1268, 2622, 43, 2496, 2082, 1547, 1546, 2143, 395, 1432, 2294, 679, 483, 1858, 1304, 1429, 1101, 2898, 1553, 1971, 1926, 641, 1145, 2957, 2694, 2695, 1791, 975, 2006, 2558, 41, 1757, 40, 163, 1367, 27, 2907, 1356, 1358, 2514, 615, 2049, 2198, 2682, 2004, 2936, 2267, 1886, 2386, 2799, 1627, 2413, 2122, 1164, 2423, 1503, 2338, 2158, 2080, 2657, 1838, 2354, 2429, 2811, 791, 969, 1784, 1874, 2149, 1585, 2946, 1615, 1246, 2935, 1934, 2046, 2718, 2577, 1868, 2893, 1896, 2434, 2330, 1104, 868, 455, 1712, 259, 1982, 314, 355, 847, 269, 643, 705, 34, 860, 1118, 1183, 756, 2189, 1918, 1625, 623, 1715, 2150, 2029, 703, 1684, 2074, 296, 226, 1788, 2073, 704, 429, 707, 1685, 1731, 1799, 458, 311, 2170, 291, 1102, 1557, 974, 2171, 1170, 2026, 1740, 597, 1241, 2190, 1297, 103, 120, 512, 482, 693, 599, 947, 1996, 673, 2065, 74, 2949, 633, 648, 657, 2199, 1550, 1453, 276, 403, 517, 1975, 1714, 245, 649, 334, 898, 285, 605, 427, 752, 622, 1257, 354, 653, 366;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 6 of 15

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0006-2026

Recall number: Z-0006-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 501 units (212 US, 289 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722008, (2) 722013; UDI-DI: (1) N/A, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270, 524, 106, 224, 463, 197, 264, 100, 294, 246, 357, 212, 287, 154, 459, 71, 112, 472, 483, 465, 419, 38, 454, 2470, 441, 460, 369, 407, 102, 231, 94, 437, 420, 1178, 108, 270, 442, 521, 372, 113, 34, 187, 254, 365, 390, 413, 52, 18, 19, 239, 288, 424, 279, 115, 481, 141, 304, 267, 361, 415, 178, 245, 445, 23, 296, 487, 349, 456, 470, 386, 69, 1236, 37, 59, 455, 217, 446, 272, 160, 406, 350, 167, 247, 416, 435, 48, 447, 179, 410, 196, 458, 525, 480, 476, 370, 327, 169, 121, 259, 266, 128, 186, 290, 385, 253, 450, 359, 391, 283, 323, 205, 425, 346, 388, 376, 150, 394, 123, 339, 513, 337, 93, 268, 200, 87, 110, 46, 542, 530, 334, 122, 468, 250, 482, 63, 305, 213, 546, 273, 433, 475, 398, 31, (2) 505, 313, 217, 492, 34, 410, 153, 360, 290, 74, 83, 241, 404, 126, 244, 106, 383, 346, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 402, 214, 86, 603, 149, 424, 140, 254, 255, 266, 475, 519, 518, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 308, 264, 78, 268, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 72, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 170, 379, 84, 125, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 304, 634, 147, 15, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 343, 223, 385, 165, 453, 370, 22, 367, 108, 352, 291, 71, 259, 455, 468, 368, 239, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 184, 185, 187, 188, 437, 189, 183, 186, 190, 413, 191, 560, 490, 300, 295, 81, 448, 444, 400, 632, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 48, 476, 527, 276, 247, 156, 499, 50, 167, 132, 302, 618, 608, 265, 70, 457, 547, 312, 321, 366, 390, 544, 236, 157, 243, 144, 525, 238, 570, 161, 349, 359, 454, 613, 623, 222, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 509, 470, 378, 296, 227, 31, 58, 589, 616, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 2266, 528, 318, 29, 28, 237, 559, 372, 256, 374, 487, 405, 380, 434, 130, 473, 551, 557, 294, 412, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 622, 182, 574, 139, 137, 250, 563, 502, 450, 436, 406, 524, 354, 510, 395, 458, 261, 503, 348, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 501, 522, 64, 396, 408, 208, 555, 394, 57, 493, 201;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 7 of 15

Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0007-2026

Recall number: Z-0007-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 4 units (2 US, 2 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722020, (2) 722025; UDI-DI: (1) N/A, (2) 00884838059108; Serial Numbers: (1) 4, (2) 2, 3, 6;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 8 of 15

Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0008-2026

Recall number: Z-0008-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 298 units (72 US, 226 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: (1) 722015, (2) 722023, (3) 722035; UDI-DI: (1) N/A, (2) 00884838059085, (3) 00884838054240; Serial Numbers: (1) 12, 2, 16, 8, 23, 3, 13, (2) 27, 116, 12, 175, 98, 35, 72, 142, 179, 46, 64, 110, 124, 66, 117, 109, 42, 138, 83, 82, 127, 75, 118, 41, 146, 33, 165, 121, 3, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 2, 158, 86, 34, 132, 9, 108, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 67, 94, 87, 57, 125, 73, 106, 16, 96, 58, 99, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150, (3) 243, 123, 38, 85, 101, 117, 212, 21, 172, 183, 252, 236, 88, 57, 143, 125, 145, 161, 244, 119, 100, 165, 47, 126, 127, 52, 247, 131, 124, 89, 169, 46, 245, 246, 242, 74, 30, 192, 60, 59, 196, 216, 187, 121, 34, 222, 72, 111, 128, 227, 174, 144, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 232, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 265, 83, 53, 32, 164, 56, 40, 11, 10, 62, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 92, 151, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 9 of 15

Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0009-2026

Recall number: Z-0009-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 87 units (21 US, 66 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 95, 126, 110, 56, 55, 57, 31, 26, 49, 114, 128, 108, 103, 107, 81, 43, 52, 119, 118, 80, 78, 47, 106, 123, 96, 122, 14, 127, 101, 116, 102, 115, 19, 109, 120, 92, 69, 27, 46, 93, 51, 50, 124, 87, 20, 29, 32, 104, 34, 45, 59, 79, 24, 70, 39, 66, 82, 75, 40, 33, 23, 25, 85, 37, 44, 58, 38, 61, 98, 53, 89, 35, 48;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 10 of 15

Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0010-2026

Recall number: Z-0010-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 300 units (69 US, 231 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722058; UDI-DI: 00884838059115; Serial Numbers: 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 172, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 366, 340, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 399, 72, 332, 92, 142, 67, 106, 335, 360, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 288, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 48, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 101, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 370, 387, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 379, 331, 418, 356, 421, 369, 420, 397, 357, 408, 393, 388, 108, 211, 126, 125, 301, 12, 30, 355, 354, 159, 139, 128, 81, 58, 96, 343, 177, 115, 19, 18, 311, 220, 386, 291, 327, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 400, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 11 of 15

Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0011-2026

Recall number: Z-0011-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 8 units (2 US, 6 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722059; UDI-DI: 00884838059122; Serial Numbers: 7, 33, 35, 40, 38, 41, 37, 2;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 12 of 15

Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0012-2026

Recall number: Z-0012-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 115 units (34 US, 81 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722038; UDI-DI: 00884838054226; Serial Numbers: 39, 63, 42, 55, 67, 99, 60, 71, 141, 115, 7, 78, 108, 106, 167, 118, 130, 49, 119, 126, 173, 38, 37, 48, 62, 35, 137, 120, 157, 41, 131, 96, 70, 46, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 133, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 122, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 28, 29;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 13 of 15

Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0013-2026

Recall number: Z-0013-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 5 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722039; UDI-DI: 00884838054271; Serial Numbers: 2, 4, 5, 6, 8;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 14 of 15

Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0014-2026

Recall number: Z-0014-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 53 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722031; UDI-DI: N/A; Serial Numbers: 29, 77, 23, 18, 45, 90, 164, 30, 76, 32, 75, 33, 40, 13, 113, 111, 46, 25, 130, 26, 61, 78, 42, 167, 49, 64, 41, 71, 20, 17, 63, 39, 9, 55, 36, 73, 48, 53, 31, 96, 28, 154, 166, 15, 84, 47, 35, 24, 148, 50, 79, 62, 66;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 15 of 15

Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0015-2026

Recall number: Z-0015-2026
Initiated: September 03, 2025
Classification: Class II
Status: Ongoing
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity: 313 units (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information

Model Numbers: 722400; UDI-DI: N/A; Serial Numbers: 282, 91, 206, 472, 187, 486, 480, 71, 322, 280, 506, 429, 413, 497, 507, 502, 222, 103, 53, 510, 43, 439, 489, 55, 176, 76, 364, 209, 382, 178, 243, 16, 74, 158, 113, 303, 4, 101, 131, 334, 93, 156, 347, 552, 482, 414, 112, 60, 42, 82, 407, 338, 33, 184, 153, 189, 424, 201, 245, 122, 273, 228, 79, 307, 476, 57, 196, 533, 217, 225, 314, 432, 81, 458, 491, 361, 2, 308, 89, 321, 525, 519, 511, 148, 100, 258, 63, 62, 22, 130, 221, 135, 159, 352, 49, 143, 31, 254, 363, 434, 223, 174, 137, 257, 232, 269, 161, 471, 470, 155, 150, 136, 440, 545, 279, 6, 149, 346, 317, 369, 119, 495, 547, 348, 110, 86, 380, 61, 341, 438, 437, 513, 459, 379, 355, 64, 485, 503, 290, 186, 168, 400, 498, 278, 283, 512, 487, 236, 455, 276, 173, 448, 92, 83, 251, 139, 160, 109, 522, 319, 381, 68, 291, 199, 67, 233, 539, 504, 190, 535, 116, 479, 423, 473, 296, 285, 449, 329, 508, 292, 398, 230, 548, 523, 299, 494, 286, 300, 488, 541, 543, 427, 447, 542, 262, 536, 469, 430, 529, 554, 555, 546, 375, 534, 521, 419, 344, 433, 463, 443, 483, 357, 374, 277, 530, 337, 549, 441, 320, 445, 287, 556, 446, 527, 526, 532, 418, 51, 544, 444, 69, 23, 250, 272, 252, 106, 224, 37, 90, 267, 229, 202, 393, 218, 550, 524, 540, 284, 557, 316, 121, 77, 147, 353, 553, 376, 132, 133, 389, 496, 368, 454, 315, 34, 240, 97, 531, 28, 9, 297, 538, 197, 415, 21, 151, 227, 528, 259, 256, 152, 330, 264, 193, 386, 44, 188, 220, 462, 356, 551, 396, 460, 249, 412, 157, 244, 78, 395, 212, 478, 499, 515, 271, 306, 435, 501, 518, 140, 226, 114, 360, 370, 477;

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Event summary

Source snapshots represented here

Every recalled product in this event

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