Device recall
Z-1310-06: EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software…
FDA device recall · Class II · Edwards Lifesciences Llc
Key facts
| Recall number (Z-number) | Z-1310-06 |
|---|---|
| Recall event | 35777 |
| Product | EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only. Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM. |
| Product code | DYG |
| Recalling firm | Edwards Lifesciences Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2008 |
| 510(k) numbers | K902628 |
| FEI number | 2015691 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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