Events

Recall of Device Recall nordicICE v 2.3.14

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
    78467
  • Event Risk Class
    Class 2
  • Event Number
    Z-2061-2018
  • Event Initiated Date
    2015-07-03
  • 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=159628
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    The bug causes bold activation maps to be visualized as overlays without taking the coregistration into account. any output created from these activation maps as overlays will not be adjusted according to the coregistration.
  • Action
    The firm notified their customers by email on July 3, 2015. Actions to be taken by the customer/User: We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below. For further questions, please call (262) 337-2909.

Device

Device Recall nordicICE v 2.3.14
  • Model / Serial
    Version 2.3.14
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
  • Product Description
    nordicICE v 2.3.14 || nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

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