Device recall
Z-0649-2010: Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors…
FDA device recall · Class II · Spacelabs Healthcare, Incorporated
Key facts
| Recall number (Z-number) | Z-0649-2010 |
|---|---|
| Recall event | 53779 |
| Product | Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. |
| Product code | DXJ |
| Recalling firm | Spacelabs Healthcare, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2011 |
| 510(k) numbers | K972282 |
| 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