Device recall
Z-1771-2013: Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation…
FDA device recall · Class II · Del Mar Reynolds Medical, Ltd.
Key facts
| Recall number (Z-number) | Z-1771-2013 |
|---|---|
| Recall event | 65630 |
| Product | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic… |
| Product code | CBK |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2013 |
| 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