FDA Device recall Z-2504-2025
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series by Philips Medical Systems Nederland B V, citing potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2504-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-01 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Model Number 722013. 9. Allura Xper FD20 OR Table, Model Number 722023. 10. Allura Xper FD10, Model Number 722026. 11. Allura Xper FD10/10, Model Number 722027. 12. Allura Xper FD20, Model Number 722028. 13. Allura Xper FD20/10, Model Number 722029. 14. Allura Xper FD20 OR Table, Model Number 722035. 15. Allura Xper FD20/20, Model Number 722038. 16. Allura Xper FD20/15, Model Number 722058. 510(k) Numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859.
Reason
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Identifiers
| code_info | 1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077, 464. 2. Model Number/System Code (…1. Model Number/System Code (UDI); Serial Numbers: 722003 (No UDI); 292, 314, 1077, 464. 2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 54. 3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 2126, 2200, 1560, 1921, 1724, 1219. 4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 516, 142, 434, 418, 480. 5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 33, 968, 763, 215, 1425, 1126, 818, 1028, 1043, 608, 907, 50, 1390, 706, 900, 1439, 1152, 165, 62, 1031, 1088, 741, 840, 413. 6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308, 344, 243, 266, 231, 286, 369, 378, 259, 333. 7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 2898, 2896, 1594, 1249, 2057, 2135, 2857, 792, 2841, 1334, 1550, 2868, 2912, 1094, 2282, 1681, 1332, 2032, 2076, 176, 835, 626, 1320, 1439, 1667. 8. Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 115, |
|---|
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-2504-2025%22
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