Device recall
Z-1546-2008: Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full…
FDA device recall · Class III · Lorad, A Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1546-2008 |
|---|---|
| Recall event | 47386 |
| Product | Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810 |
| Product code | MUE |
| Recalling firm | Lorad, A Hologic, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 3, 2009 |
| 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