Device recall
Z-1556-2009: GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-1556-2009 |
|---|---|
| Recall event | 52015 |
| Product | GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. |
| Product code | LNH |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2013 |
| 510(k) numbers | K053009 |
| 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