Device recall
Z-0114-2012: 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-0114-2012 |
|---|---|
| Recall event | 59326 |
| Product | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of… |
| Product code | MUE |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 16, 2012 |
| PMA numbers | P990066 |
| 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