Device recall
Z-3023-2018: fMRI Hardware System VisualSystem allows video signals from the stimulus…
FDA device recall · Class II · NordicNeuroLab AS
Key facts
| Recall number (Z-number) | Z-3023-2018 |
|---|---|
| Recall event | 80529 |
| Product | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1 |
| Product code | LNH |
| Recalling firm | NordicNeuroLab AS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2020 |
| 510(k) numbers | K092253 |
| 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