Device recall
Z-1284-2010: NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1284-2010 |
|---|---|
| Recall event | 53869 |
| Product | NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in neonatal, pediatric and… |
| Product code | CCK |
| Recalling firm | Philips Healthcare Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2016 |
| 510(k) numbers | K030886 |
| FEI number | 1218950 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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