FDA Device recall Z-2624-2025
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005
- FDA Device
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005 by Philips Medical Systems Nederland B V, citing systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration oc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2624-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-03 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Reason
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Identifiers
| code_info | Product Codes: (1)722011, (2) 722027, (3) 722005; UDI-DI: (1) 00884838059047, (2) 00884838054196, (3) N/A; Serial numbe…Product Codes: (1)722011, (2) 722027, (3) 722005; UDI-DI: (1) 00884838059047, (2) 00884838054196, (3) N/A; Serial numbers: (1) 157, 268, 95, 107, 59, 319, 49, 170, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 87, 255, 171, 362, 168, 275, 344, 324, 163, 103, 215, 328, 286, 81, 293, 294, 224, 117, 334, 338, 146, 145, 266, 21, 202, 165, 367, 372, 340, 318, 98, 211, 158, 271, 204, 246, 206, 321, 295, 104, 217, 265, 261, 125, 282, 216, 333, 329, 230, 198, 244, 292, 180, 183, 314, 337, 341, 376, 377, 378, 259, 347, 287, 99, 233, 156, 71, 77, 188, 223, 238, 153, 129, 278, 118, 186, 108, 89, 258, 310, 274, 139, 141, 86, 300, 88, 309, 227, 220, 242, 166, 299, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 116, 112, 114, 43, 313, (2) 123, 133, 134, 183, 106, 169, 107, 42, 101, 209, 153, 40, 156, 112, 1, 104, 71, 175, 116, 174, 29, 50, 56, 152, 43, 49, 202, 178, 127, 39, 27, 64, 78, 99, 6, 86, 7, 145, 102, 44, 142, 30, 79, 38, 85, 181, 144, 177, 165 |
|---|
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-2624-2025%22
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