Device recall
Z-2068-2023: OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that…
FDA device recall · Class II · NeuroLogica Corporation
Key facts
| Recall number (Z-number) | Z-2068-2023 |
|---|---|
| Recall event | 92506 |
| Product | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000 |
| Product code | JAK |
| Recalling firm | NeuroLogica Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171183 |
| FEI number | 3004938766 |
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