Device recall
Z-2219-2025: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the…
FDA device recall · Class II · FUJIFILM Healthcare Americas Corporation
Key facts
| Recall number (Z-number) | Z-2219-2025 |
|---|---|
| Recall event | 97063 |
| Product | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). |
| Product code | OTE |
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P160031 |
| FEI number | 1000513161 |
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