Device recall
Z-1144-2015: Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs…
FDA device recall · Class II · Spacelabs Healthcare Inc
Key facts
| Recall number (Z-number) | Z-1144-2015 |
|---|---|
| Recall event | 70453 |
| Product | Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key… |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 30, 2015 |
| 510(k) numbers | K112962 |
| 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