Device recall
Z-2301-2013: Selenia Full Field Digital Mammography System with software versions 5.0.x and…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-2301-2013 |
|---|---|
| Recall event | 66195 |
| Product | Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for… |
| Product code | MUE |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2013 |
| PMA numbers | P010025 |
| FEI number | 1220984 |
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