Device recall
Z-1193-2019: EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage…
FDA device recall · Class I · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-1193-2019 |
|---|---|
| Recall event | 82456 |
| Product | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor). |
| Product code | DXN |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 28, 2023 |
| 510(k) numbers | K160552 |
| 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