Device recall
Z-0517-06: Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas…
FDA device recall · Class II · Spacelabs Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0517-06 |
|---|---|
| Recall event | 32815 |
| Product | Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status. |
| Product code | CCK |
| Recalling firm | Spacelabs Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2006 |
| 510(k) numbers | K031124 |
| FEI number | 3010157426 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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