Events

Rappel de Device Recall Merge Eye Care PACS Viewer 5.2

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
    77627
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2754-2017
  • Date de mise en oeuvre de l'événement
    2017-06-13
  • Date de publication de l'événement
    2017-07-10
  • 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=156932
  • 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 management, ophthalmic - Product Code NFJ
  • Cause
    When the user has not set up any user preference on the sorting order to render the study images (os/od/etc.) and reports, the ecp may get an incorrect study index. if the user attempts to delete an image, ecp may then read that image as os when it is, in fact, od.
  • Action
    The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.

Device

Device Recall Merge Eye Care PACS Viewer 5.2
  • Modèle / numéro de série
    Version 5.2
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    FL, IL, CO, MI, CA, NY, ND, OH, CT
  • Description du dispositif
    Merge Eye Care PACS Viewer 5.2 || Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. || Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. || Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.