Device recall
Z-1125-2017: Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1125-2017 |
|---|---|
| Recall event | 76062 |
| Product | Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg. |
| Product code | DQA |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2018 |
| 510(k) numbers | K904039 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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