Product Wiki · Recalls · U.S. FDA — Device Enforcement

fMRI Hardware System — recall Z-2103-2018

U.S. FDA — Device Enforcement · Norway · 2017-10-28 · Class II

As described by U.S. FDA — Device Enforcement: 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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2103-2018
Date of alert
2017-10-28
Country / jurisdiction
Norway
Risk level
Class II
Risk type
recall
Brand
NordicNeuroLab AS
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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
Reported risk: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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