Allura Xper FD10 and FD20 — Class II medical device recall Z-2283-2023
Ongoing recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., reported 2023-08-09, distributed nationwide. The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspens
| Recall number | Z-2283-2023 |
|---|---|
| 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 | 2023-06-12 |
| Classified | 2023-08-02 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, ID, IE, IR, IT, JO, JP, KE, KR, LT, MA, MY, NL, NO, NZ, OM, PA, PH, PL, PT, RU, SA, SE, SG, TH, TR, TW, UY, VN, ZA |
| Quantity | 648 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00884838054189, 00884838054202, 00884838054240, 00884838059054, 00884838059085, 00884838059191, 00884838059283 |
| Model numbers | 722010, 722012, 722022, 722023, 722026, 722028, 722033, 722035 |
Product
Allura Xper FD10 and FD20. X-ray Imaging System.
Reason for recall
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
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-2283-2023. 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.