Events

Retiro De Equipo (Recall) de Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM

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
    75914
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1246-2017
  • Fecha de inicio del evento
    2016-03-28
  • 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=151691
  • 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
    Eye station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an medical record number (mrn).
  • Acción
    The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.

Device

Device Recall OLS Symphony. DFC1024 & DFC512 DIGITAL IMAGING SYSTEM
  • Modelo / Serial
    Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
  • Descripción del producto
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.