Device recall
Z-1293-2010: 100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product…
FDA device recall · Class II · Philips Healthcare Inc.
Key facts
| Recall number (Z-number) | Z-1293-2010 |
|---|---|
| Recall event | 53869 |
| Product | 100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The 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… |
| 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