Device recall
Z-1343-2020: Selenia Dimensions Mammography System, Model number ASY-04160, Selenia…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1343-2020 |
|---|---|
| Recall event | 84882 |
| Product | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, |
| Product code | MUE |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2021 |
| PMA numbers | P010025, P010025S013, P080003 |
| 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