Device recall
Z-2134-2016: Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when…
FDA device recall · Class II · Karl Storz Endoscopy
Key facts
| Recall number (Z-number) | Z-2134-2016 |
|---|---|
| Recall event | 74515 |
| Product | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope |
| Product code | FET |
| Recalling firm | Karl Storz Endoscopy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2017 |
| 510(k) numbers | K131953 |
| FEI number | 3007475226 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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