Device recall
Z-1147-2014: GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1147-2014 |
|---|---|
| Recall event | 67430 |
| Product | GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed… |
| Product code | MHX |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2015 |
| 510(k) numbers | K071073 |
| FEI number | 2126677 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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