Events

Retiro De Equipo (Recall) de Device Recall Merge Eye Care PACS Viewer 5.2

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Merge Healthcare, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77627
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2754-2017
  • Fecha de inicio del evento
    2017-06-13
  • Fecha de publicación del evento
    2017-07-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156932
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, image management, ophthalmic - Product Code NFJ
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Version 5.2
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    FL, IL, CO, MI, CA, NY, ND, OH, CT
  • Descripción del producto
    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.