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.
FDA Recall Z-2103-2018 · Posted None
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Recalling FirmNordicNeuroLab AS
Recall StatusTerminated
Product CodeLNH
Date Initiated2017-10-28
Date Terminated2021-03-31
Product Quantity64 units
Reason for Recall
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Firm Action
The firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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