Device recall
Z-1043-2011: GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-1043-2011 |
|---|---|
| Recall event | 57763 |
| Product | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer. |
| Product code | MUE |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2012 |
| FEI number | 2126677 |
At a glance
- None 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