Recall Z-2103-2018— NordicNeuroLab AS

Name: FDA recall Z-2103-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-28

Class II · Terminated

Class II FDA medical device recall by NordicNeuroLab AS, initiated 2017-10-28, terminated 2021-03-31. It names one FDA 510(k) clearance: K080515. 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.. Reason: Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones..

Recalling firm: NordicNeuroLab AS
Classification: Class II
Status: Terminated
Initiated: 2017-10-28
Terminated: 2021-03-31
Firm location: Bergen, N/A, Norway

510(k) clearances named in this recall

1 on FDA's record

K080515 — FMRI HARDWARE SYSTEMNordicneurolab·cleared 2008-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.