Device recall
Z-0845-2014: InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V)…
FDA device recall · Class II · Philips Healthcare
Key facts
| Recall number (Z-number) | Z-0845-2014 |
|---|---|
| Recall event | 67319 |
| Product | InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908 |
| Product code | NCX |
| Recalling firm | Philips Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2014 |
| 510(k) numbers | K080908 |
| FEI number | 3003888399 |
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