Device recall
Z-0285-2009: GE Healthcare Solar 8000M System, a multiparameter physiological patient…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-0285-2009 |
|---|---|
| Recall event | 49135 |
| Product | GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment |
| Product code | DSI |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2012 |
| 510(k) numbers | K012467 |
| FEI number | 3004526608 |
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