Drug recall
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product…
FDA recall event 66980 · Class II · EOS Imaging
Key facts
| Event ID | 66980 |
|---|---|
| Recall numbers | Z-0580-2014 |
| Recalling firm | EOS Imaging |
| Product type | Devices |
| Products | steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation |
| Initiation date | Nov 29, 2013 |
| Report date | Jan 1, 2014 |
| Termination date | Jan 13, 2015 |
| City | Paris France |
| Country | France |
| FEI number | 3006165260 |
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: