Device recall
Z-1134-2021: SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor…
FDA device recall · Class II · SenTec AG
Key facts
| Recall number (Z-number) | Z-1134-2021 |
|---|---|
| Recall event | 87054 |
| Product | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital… |
| Product code | LKD |
| Recalling firm | SenTec AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2026 |
| 510(k) numbers | K041548, K101690, K151329 |
| 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