Device recall
Z-2103-2018: fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory…
FDA device recall · Class II · NordicNeuroLab AS
Key facts
| Recall number (Z-number) | Z-2103-2018 |
|---|---|
| Recall event | 78848 |
| Product | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a… |
| Product code | LNH |
| Recalling firm | NordicNeuroLab AS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2021 |
| 510(k) numbers | K080515 |
| 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