Device recall
Z-2772-2020: OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with…
FDA device recall · Class II · NeuroLogica Corporation
Key facts
| Recall number (Z-number) | Z-2772-2020 |
|---|---|
| Recall event | 86052 |
| Product | OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. |
| Product code | JAK |
| Recalling firm | NeuroLogica Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2021 |
| 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