Sedecal X Optima URS digital mobile diagnostic x-ray system — Class II medical device recall Z-0781-2024
Ongoing recall by SEDECAL SA, reported 2024-01-31, distributed in AL, FL, NC. Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
| Recall number | Z-0781-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEDECAL SA, Algete, N/A, Spain |
| Recall initiated | 2023-12-13 |
| Classified | 2024-01-22 |
| Reported by FDA | 2024-01-31 |
| Distributed | AL, FL, NC |
| Quantity | 845 units |
| UPC / GTIN / UDI-DI | 08436046002500 |
Product
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
Reason for recall
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
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-0781-2024. 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.