Device recall
Z-2902-2011: Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs…
FDA device recall · Class III · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-2902-2011 |
|---|---|
| Recall event | 59136 |
| Product | Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare Llc. Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being… |
| Product code | CBR |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 21, 2011 |
| 510(k) numbers | K053599 |
| FEI number | 3010157426 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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