Device recall
Z-2019-2012: Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-2019-2012 |
|---|---|
| Recall event | 62437 |
| Product | Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter… |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 28, 2012 |
| 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