Rappel de Device Recall Merge RadSuite 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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 values provided from the pixel value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
  • Action
    Merge sent an Urgent Medical Device Recall letter dated March 28, 2016 to all affected customers. The letter notifies the customer of the issue and informs them an upgrade is available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they are interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. The response was required no later than April 18, 2016. A second letter dated July 11, 2016, was issued asking for a response by August 2, 2016, even though all upgrades were made because the effectiveness checks were not yet completed. The letter and response form contained the same information as the first letter. The recalling firm reported emails were tracked for delivery confirmation and the letters were tracked for delivery by USPS certified services. For further questions, please call 877-744-5369.


  • Modèle / numéro de série
    Version V8.30.7.8
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
  • Description du dispositif
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer