Drug recall
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus…
FDA recall event 78848 · Class II · NordicNeuroLab AS
Key facts
| Event ID | 78848 |
|---|---|
| Recall numbers | Z-2103-2018 |
| Recalling firm | NordicNeuroLab AS |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. |
| Initiation date | Oct 28, 2017 |
| Report date | Jun 13, 2018 |
| Termination date | Mar 31, 2021 |
| City | Bergen |
| Country | Norway |
| FEI number | 3006738448 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: