Device recall
Z-1852-2014: Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the…
FDA device recall · Class II · Spacelabs Healthcare Inc
Key facts
| Recall number (Z-number) | Z-1852-2014 |
|---|---|
| Recall event | 68491 |
| Product | Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 17, 2015 |
| 510(k) numbers | K120616 |
| FEI number | 3010157426 |
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