Device recall
Z-2199-2012: SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for…
FDA device recall · Class II · Sentec AG
Key facts
| Recall number (Z-number) | Z-2199-2012 |
|---|---|
| Recall event | 62589 |
| Product | SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). |
| Product code | LKD |
| Recalling firm | Sentec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 11, 2012 |
| 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