Philips Allura R8 — Class II medical device recall Z-2189-2025
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2025-08-06, distributed nationwide. Potential for temporary loss of imaging (X-ray) functionality due to software issue.
| Recall number | Z-2189-2025 |
|---|---|
| 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 | 2025-06-30 |
| Classified | 2025-07-29 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KY, LB, LK, LT, MA, MT, MX, MY, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SK, TH, TN, TT, TW, UA, UY, VN, ZA |
| Quantity | 4,508 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054196, 00884838054202, 00884838054219, 00884838054226, 00884838054233, 00884838054240, 00884838054271, 00884838059115, 00884838059122 |
| Model numbers | 722026, 722027, 722028, 722029, 722033, 722035, 722038, 722039, 722058, 722059 |
Product
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.
Reason for recall
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
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-2189-2025. 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.