Device recall
Z-2168-2011: Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N…
FDA device recall · Class II · Respironics Novametrix, LLC.
Key facts
| Recall number (Z-number) | Z-2168-2011 |
|---|---|
| Recall event | 57594 |
| Product | Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. |
| Recalling firm | Respironics Novametrix, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2013 |
| 510(k) numbers | K080652, K091459, K092217 |
| FEI number | 1219324 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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