FDA Device recall Z-0008-2026
Allura Xper FD20 OR Table
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Allura Xper FD20 OR Table 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-0008-2026 |
| 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 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; 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) 722015, (2) 722023, (3) 722035; UDI-DI: (1) N/A, (2) 00884838059085, (3) 00884838054240; Serial Numb…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 |
|---|
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-0008-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.