NordicNeuroLab fMRI AudioSystem Recalled for Acoustic Distortion and Heat

Plain-English summary

NordicNeuroLab AS is recalling 64 units of the fMRI Hardware System - AudioSystem, Version 1.0. The device allows auditory signals from a stimulus presentation PC to enter the scanner room and be presented to the patient, and includes a communication console for the operator to adjust sounds and speak to the patient.

The recall was initiated after a report of an interrupted MR scan. During the incident, a patient complained about acoustic distortion and heat felt from the headphones. The affected units are identified by the codes HPS-2015-1.0-XXX and HPS-2016-1.0-XXX.

The recalled devices were distributed worldwide, including in the United States, Russia, Israel, Norway, South Korea, China, France, South Africa, Japan, Poland, Chile, Switzerland, Australia, Belgium, Lithuania, the United Kingdom, and Bulgaria. Users should stop using the affected AudioSystem units and contact NordicNeuroLab AS for further instructions.

The recalled product

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

Manufacturer

NordicNeuroLab AS

Category

Medical Device — fMRI Hardware

Hazard

• heat
• acoustic-distortion

Affected units

64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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