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Recall Observatory FDA recall evidence

Device 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.

Z-2103-2018

October 28, 2017

Class II

Product summary

Firm
NordicNeuroLab AS
Event
Event 78848
Status
Terminated
Classification
Class II
Quantity
64 units
Official record key
device-enforcement:Z-2103-2018

Official wording

Reason: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

Code information: HPS-2015-1.0-XXX HPS-2016-1.0-XXX

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.

Field note

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