Sedecal NOVA FA DR System — Class II medical device recall Z-0488-2019
Ongoing recall by Sedecal S.A., reported 2018-11-28. A safety problem with installation and maintenance could lead to the breakage of the two steel cables that sup
| Recall number | Z-0488-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sedecal S.A., Algete, N/A, Spain |
| Recall initiated | 2018-07-18 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Countries outside the US | CA |
| Quantity | 145 units |
| Reason classes | device malfunction |
| Serial numbers | 07360816 |
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
Reason for recall
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
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-0488-2019. 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.