Device recall
Z-2768-2016: Certegra Workstation used in conjunction with Medrad Stellant CT Injection…
FDA device recall · Class II · Bayer Healthcare
Key facts
| Recall number (Z-number) | Z-2768-2016 |
|---|---|
| Recall event | 74974 |
| Product | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography… |
| Product code | DXT |
| Recalling firm | Bayer Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 9, 2016 |
| 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