Device recall
Z-1501-2015: Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof…
FDA device recall · Class II · SenTec AG
Key facts
| Recall number (Z-number) | Z-1501-2015 |
|---|---|
| Recall event | 70878 |
| Product | Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse… |
| Product code | LKD |
| Recalling firm | SenTec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2016 |
| 510(k) numbers | K101690 |
| FEI number | 3004149774 |
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