Philips Allura Xper Systems — Class II medical device recall Z-0676-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2024-12-18, distributed nationwide. Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not instal
| Recall number | Z-0676-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands |
| Recall initiated | 2024-11-11 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, KY, LB, LT, LV, MA, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PH, PL, PT, PY, QA, RO, SA, SE, SG, SI, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 2,782 units |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838059030, 00884838059054 |
| Serial numbers | 100, 1000, 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 101, 1010, 1011, 1012, 1014, 1015, 1016, 1017, 1018, 1019, 102, 1020, 1021, 1022 and 475 more |
| Model numbers | 722010, 722011, 722012, 722013, 722022, 722023, 722025 |
Product
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
Reason for recall
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
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-0676-2025. 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.