NordicNeuroLab AS: Medical Device Recall in 2018 - (Recall #: Z-2103-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 28, 2017

Date Posted: June 13, 2018

Recall Number: Z-2103-2018

Event ID: 78848

Reason for Recall:

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

Status: Terminated

Product Quantity: 64 units

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

Voluntary or Mandated:

Voluntary: Firm initiated