Device recall
Z-2045-2018: nordicBrainEX Product Usage: nordicBrainEx is an image processing software…
FDA device recall · Class II · NordicNeuroLab AS
Key facts
| Recall number (Z-number) | Z-2045-2018 |
|---|---|
| Recall event | 80162 |
| Product | nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing… |
| Product code | LLZ |
| Recalling firm | NordicNeuroLab AS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2020 |
| 510(k) numbers | K092102 |
| 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