Device recall
Z-2343-2015: PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for…
FDA device recall · Class I · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2343-2015 |
|---|---|
| Recall event | 71702 |
| Product | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients. |
| Product code | CBK |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 1, 2017 |
| 510(k) numbers | K093632 |
| FEI number | 2517967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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