Device recall
Z-1705-2014: Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector…
FDA device recall · Class II · Spacelabs Healthcare Inc
Key facts
| Recall number (Z-number) | Z-1705-2014 |
|---|---|
| Recall event | 68357 |
| Product | Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment. |
| Product code | DSI |
| Recalling firm | Spacelabs Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2014 |
| 510(k) numbers | K103142 |
| 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