Events

Rappel de DR Systems Unity PACS software, now known as Merge Unity PACS software.

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 Merge Healthcare, Inc..

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
    75876
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0939-2017
  • Date de mise en oeuvre de l'événement
    2015-10-15
  • 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=151514
  • 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
    The software fails to associate to the correct mg image if there are two images for the same view.
  • Action
    Merge sent an Urgent : Medical Device Recall letter dated July 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Be aware of the following workaround: Customer I User: Ensure both" tome" images are reviewed when more than one is captured for the same view. Merge has a released fix available for this issue. YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED Please reply using the enclosed form and the return addressed envelope. Your response is required no later than August 2,2016. For further questions regarding this recall please call (877) 741-5369

Device

DR Systems Unity PACS software, now known as Merge Unity PACS software.
  • Modèle / numéro de série
    Version 11.0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to medical facilities located in MT, CA, PA, and TX.
  • Description du dispositif
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.