Device recall
Z-2417-2015: Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2417-2015 |
|---|---|
| Recall event | 71739 |
| Product | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring… |
| Product code | LKD |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2016 |
| 510(k) numbers | K093154 |
| FEI number | 3010420736 |
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