Class II — NordicNeuroLab AS
| Recalling firm | NORDICNEUROLAB AS |
|---|---|
| Registered facility | NORDICNEUROLAB AS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. |
| 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 built-in microphone. |
| Quantity | 64 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Russia, Israel. Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland. Australia, Belgium, Lithuania, United Kingdom and Bulgaria |
| Initiated | 2017-10-28 |
| Classified | 2018-06-06 |
| Terminated | 2021-03-31 |
| Recall number | Z-2103-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — NordicNeuroLab AS (Z-2103-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78848/
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