Device recall
Z-3248-2024: Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version…
FDA device recall · Class II · Hologic Inc
Key facts
| Recall number (Z-number) | Z-3248-2024 |
|---|---|
| Recall event | 95286 |
| Product | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT… |
| Product code | OTE |
| Recalling firm | Hologic Inc |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P080003 |
| FEI number | 3005496266 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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