Device recall
Z-0580-2014: steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing…
FDA device recall · Class II · EOS Imaging
Key facts
| Recall number (Z-number) | Z-0580-2014 |
|---|---|
| Recall event | 66980 |
| Product | 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 digital processing of two 3D x-ray images. |
| Product code | LLZ |
| Recalling firm | EOS Imaging |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2015 |
| 510(k) numbers | K130395 |
| FEI number | 3006165260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database