Events

Rappel de Device Recall nordicBrainEX

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par NordicNeuroLab AS.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    80162
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2045-2018
  • Date de mise en oeuvre de l'événement
    2012-12-21
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164721
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, image processing, radiological - Product Code LLZ
  • Cause
    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
  • Modèle / numéro de série
    version 1.1.2
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide - Saudi Arabia, Brazil, Sweden, Spain, Russia, Belgium, Norway, South Korea, Japan
  • Description du dispositif
    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
  • Adresse du fabricant
    NordicNeuroLab AS, Mollendalsveien 65c, Bergen Norway
  • Société-mère du fabricant (2017)
    Søre Øverli As
  • Source
    USFDA