FDA Device recall Z-0003-2026
Allura Xper FD10/10
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Allura Xper FD10/10 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-0003-2026 |
| 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 FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; 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) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numb…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, |
|---|
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-0003-2026%22
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