Device recall
Z-0262-2008: Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric…
FDA device recall · Class II · Edwards Lifesciences, Llc
Key facts
| Recall number (Z-number) | Z-0262-2008 |
|---|---|
| Recall event | 45464 |
| Product | Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA 92614 |
| Product code | DXG |
| Recalling firm | Edwards Lifesciences, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 9, 2009 |
| 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