Events

Recall of Device Recall nordicBrainEX

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
    80162
  • Event Risk Class
    Class 2
  • Event Number
    Z-2045-2018
  • Event Initiated Date
    2012-12-21
  • 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=164721
  • 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
    There is an error related to the relative geometry between fiber tracts in a fiber group and images. the error occurs in the following situations: a group of fibers has been selected using the voi functionality and put into a fiber group. this is done with images series a visualized in the 3d viewer. then a new images series b is visualized in the 3d viewer. if image series a and b have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking a to b will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on b in the 3d viewer. furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the mpr on b, the positioning will not be correct. the misalignment will be equal to the rotations/translations necessary to align a with b.
  • Action
    The firm distributed the recall notification letter by email. The letter identified the affected product, problem and the actions to be taken. For questions contact NordicNeurolab Customer Service or if you would like to arrange a return customerservice@nordicneurolab.com.

Device

Device Recall nordicBrainEX
  • Model / Serial
    version 1.1.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
  • Product Description
    nordicBrainEX || Product Usage: || nordicBrainEx 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.
  • Manufacturer
    NordicNeuroLab AS

Manufacturer

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