Events

Recall of nordicBrainEx 2.0

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
    78466
  • Event Risk Class
    Class 2
  • Event Number
    Z-2050-2018
  • Event Initiated Date
    2014-09-17
  • 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=159625
  • 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
    An error was discovered in the interpretation of certain dicom header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
  • Action
    The firm notified their consignees by email on 09/17/2014.

Device

nordicBrainEx 2.0
  • Model / Serial
    version 2.1 and older
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA, Sweden, Spain, Russia, Hungary, India, Norway, Iceland, Italy, South Korea, United Kingdom
  • Product Description
    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

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