Device recall
Z-2050-2018: nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic…
FDA device recall · Class II · NordicNeuroLab AS
Key facts
| Recall number (Z-number) | Z-2050-2018 |
|---|---|
| Recall event | 78466 |
| Product | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. |
| Product code | LLZ |
| Recalling firm | NordicNeuroLab AS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2021 |
| 510(k) numbers | K133910 |
| FEI number | 3006738448 |
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