Device recall
Z-1332-2022: Omnera 400A Digital Radiographic System
FDA device recall · Class II · Arcoma AB
Key facts
| Recall number (Z-number) | Z-1332-2022 |
|---|---|
| Recall event | 90446 |
| Product | Omnera 400A Digital Radiographic System |
| Product code | KPR |
| Recalling firm | Arcoma AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K140683 |
| FEI number | 3002675731 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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