FDA Device recall Z-0002-2026

Allura Xper FD10

FDA Device
Class II
ongoing
Published 2025-10-08

On 2025-10-08 the FDA classified a Class II recall of Allura Xper FD10 by Philips Medical Systems Nederland B V, citing 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 sy….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0002-2026
Classification	Class II
Status	ongoing
Initiated	2025-09-03
Published	2025-10-08
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	Model Numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) N/A, (2) 00884838059030, (3) 00884838054189; Serial Numb… 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,

code_info

Model Numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) N/A, (2) 00884838059030, (3) 00884838054189; Serial Numb…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2026%22

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