Device recall
Z-0942-2012: Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61…
FDA device recall · Class II · Edwards Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-0942-2012 |
|---|---|
| Recall event | 52807 |
| Product | Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry… |
| Product code | DXG |
| Recalling firm | Edwards Lifesciences, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2012 |
| 510(k) numbers | K043103 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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