Device recall
Z-2343-2008: Ultraview SL Command Module, Model 91496 The product is intended for use with…
FDA device recall · Class II · Spacelabs Healthcare, Incorporated
Key facts
| Recall number (Z-number) | Z-2343-2008 |
|---|---|
| Recall event | 48759 |
| Product | Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient Care Monitoring System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological… |
| Product code | DSI |
| Recalling firm | Spacelabs Healthcare, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2011 |
| 510(k) numbers | K972502 |
| 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