FDA Device recall Z-0005-2026

Allura Xper FD20

FDA Device
Class II
ongoing
Published 2025-10-08

On 2025-10-08 the FDA classified a Class II recall of Allura Xper FD20 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-0005-2026
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 FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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) 722006, (2) 722012, (3) 722028; UDI-DI: (1) N/A, (2) 00884838059054, (3) 00884838054202; Serial Numb… 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,

code_info

Model Numbers: (1) 722006, (2) 722012, (3) 722028; UDI-DI: (1) N/A, (2) 00884838059054, (3) 00884838054202; Serial Numb…

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,

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-0005-2026%22

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