Events

Rappel de Device Recall CADstream 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
    75239
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0137-2017
  • Date de mise en oeuvre de l'événement
    2016-01-30
  • 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=149746
  • 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 was not presenting the pure filter user interface message on dicom transfer studies. if a site starts using pure filter, the user interface message will not display. this may result in incorrect patient follow-up.
  • Action
    Merge Healthcare Inc. sent an Urgent Medical Device Recall letter dated January 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. In addition, the customer is requested to call Customer Service or send them an email to schedule the upgrade. If the customer chooses not to upgrade, they are requested to complete the attached form or go online and complete it. Merge Healthcare is committed to improve efficiencies and enhancing the quality of healthcare worldwide.If you have any additional questions, call Merge Customer Service at (877) 741-5369 or support@merge.com.

Device

Device Recall CADstream software
  • Modèle / numéro de série
    Versions prior to 5.2.9
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
  • Description du dispositif
    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.