Events

Recall of fMRI Hardware System AudioSystem, Version 1.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NordicNeuroLab AS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78848
  • Event Risk Class
    Class 2
  • Event Number
    Z-2103-2018
  • Event Initiated Date
    2017-10-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160719
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Report was of an interrupted mr scan after patient complained about acoustic distortion, and heat felt form the headphones.
  • Action
    The firm notified the consignees by email on September 28, 2017. The units were to be returned. For further questions, please call 1 (855) 665-3674 option 1.

Device

fMRI Hardware System AudioSystem, Version 1.0
  • Model / Serial
    HPS-2015-1.0-XXX HPS-2016-1.0-XXX
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • 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.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

NordicNeuroLab AS
  • Manufacturer Address
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • Manufacturer Parent Company (2017)
    Søre Øverli As
  • Source
    USFDA