Interventional Fluoroscopic X-Ray System — Class II medical device recall Z-2504-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-09-10, distributed nationwide. Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the A
| Recall number | Z-2504-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands |
| Recall initiated | 2025-08-01 |
| Classified | 2025-09-03 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CH, CL, CN, CO, CZ, DE, EG, ES, FI, FR, GB, HK, IN, IT, JP, KR, MY, NL, NO, OM, PK, PL, RO, SA, SE, SG, TH, VN |
| Quantity | 192 untis |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054240, 00884838059030, 00884838059047, 00884838059054, 00884838059061, 00884838059085, 00884838059115 |
| Serial numbers | 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722058 |
| Model numbers | 510, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722058 |
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 for recall
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2504-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.