Device recall
Z-0875-2026: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0875-2026 |
|---|---|
| Recall event | 98081 |
| Product | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography |
| Product code | MUE |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162268, K173576, K182951 |
| FEI number | 2126677 |
At a glance
- 1–9 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