Device recall
Z-1298-2014: Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care…
FDA device recall · Class I · Draeger Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1298-2014 |
|---|---|
| Recall event | 67502 |
| Product | Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital. |
| Product code | CBK |
| Recalling firm | Draeger Medical Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 17, 2015 |
| 510(k) numbers | K093632 |
| FEI number | 2510954 |
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