FDA Device recall Z-0006-2026
Allura Xper FD20 Biplane
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Allura Xper FD20 Biplane 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-0006-2026 |
| 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 Biplane; Model Numbers: (1) 722008, (2) 722013; 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) 722008, (2) 722013; UDI-DI: (1) N/A, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142…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, |
|---|
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-0006-2026%22
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