Device recall
Z-2589-2018: Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit…
FDA device recall · Class I · Spacelabs Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-2589-2018 |
|---|---|
| Recall event | 80462 |
| Product | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the… |
| Product code | CBK |
| Recalling firm | Spacelabs Healthcare, Ltd. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 20, 2024 |
| 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