Rappel de Merge PACS software. The firm name on the label is Merge Healthcare.

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
  • Statut de l'événement
    Open, Classified
  • Pays 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
    Studies that have qc, pde, or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
  • Action
    Merge sent an Urgent: Medical Device Recall letter dated March 28, 2016, to all affected customers via email the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A letter dated February 21, 2017 , was issued was also issued via email or certified mail. The letter notifies the customer of the issue, informs them not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis, and they should be aware of the workaround. The customer is also notified a fix is not yet available, however, the recalling firm is working on correcting the issue and will inform them once a fix is made 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 understand the workaround and are they 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 was issued dated February 21, 2017,via email or certified mail if no email address was available. The letter notified customers a fix was now available and also contained the same information and response form as the first letter. The letter informed the customer a response was required 15 calendar days after receipt of the letter. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.


  • Modèle / numéro de série
    Versions 6.6.1,, 6.6.2,,, 7.0, and 7.0.1
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution.
  • Description du dispositif
    Merge PACS software. The firm name on the label is Merge Healthcare.
  • Manufacturer