Device recall
Z-2146-2008: GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field…
FDA device recall · Class II · GE Healthcare
Key facts
| Recall number (Z-number) | Z-2146-2008 |
|---|---|
| Recall event | 49509 |
| Product | GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations. |
| Product code | IZH |
| Recalling firm | GE Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2011 |
| 510(k) numbers | K941191 |
| FEI number | 2126677 |
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