Drug recall
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or…
FDA recall event 73428 · Class II · Sedecal S.A.
Key facts
| Event ID | 73428 |
|---|---|
| Recall numbers | Z-1084-2016 |
| Recalling firm | Sedecal S.A. |
| Product type | Devices |
| Products | Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and… |
| Initiation date | Jan 18, 2016 |
| Report date | Mar 16, 2016 |
| Termination date | Feb 7, 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: