Drug recall
Sedecal NOVA FA DR System. for diagnostic radiography.
FDA recall event 81377 · Class II · Sedecal S.A.
Key facts
| Event ID | 81377 |
|---|---|
| Recall numbers | Z-0488-2019 |
| Recalling firm | Sedecal S.A. |
| Product type | Devices |
| Products | Sedecal NOVA FA DR System. for diagnostic radiography. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 18, 2018 |
| Report date | Nov 28, 2018 |
| City | Algete |
| Country | Spain |
| FEI number | 3002495042 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: