Device recall
Z-2382-2012: Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-2382-2012 |
|---|---|
| Recall event | 63007 |
| Product | Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium… |
| Product code | DSI |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2013 |
| 510(k) numbers | K842616 |
| 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