Device recall
Z-1686-2015: MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the…
FDA device recall · Class II · Medrad Inc dba Bayer R&I
Key facts
| Recall number (Z-number) | Z-1686-2015 |
|---|---|
| Recall event | 71296 |
| Product | MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. |
| Product code | DXT |
| Recalling firm | Medrad Inc dba Bayer R&I |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2015 |
| 510(k) numbers | K082905 |
| FEI number | 2520313 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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