Device recall
Z-1442-2014: SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed…
FDA device recall · Class I · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-1442-2014 |
|---|---|
| Recall event | 67781 |
| Product | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. |
| Product code | CBK |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 20, 2014 |
| 510(k) numbers | K113051 |
| FEI number | 3002807992 |
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