Phoenix mKDR Xpress — Class II medical device recall Z-1203-2023
Ongoing recall by SEDECAL SA, reported 2023-03-08. Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
| Recall number | Z-1203-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, N/A, Spain |
| Recall initiated | 2023-02-06 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Countries outside the US | AR, PA |
| Quantity | 7 units |
| UPC / GTIN / UDI-DI | 08436046003163 |
| Serial numbers | PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208 |
Product
Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Reason for recall
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
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-1203-2023. 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.