Events

Retiro De Equipo (Recall) de Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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
    RC-2016-RN-00870-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00870-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Unviewed images may not display after the last hanging protocol (hp) step when the user preference setting "show unviewed images after the last hanging protocol (mg only)" is selected. this can occur if the last hp step was skipped. this is most commonly encountered if there are additional views created for the study.This may impact diagnosis when images are unavailable for viewing, however there have been no reports of injuries as a result of this issue.
  • Acción
    Emergo is advising users to not have the red-x icon available in the reading physician's toolbars to close the study. This will trigger a warning message that there are unviewed images available. Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 27/02/2017.

Device

Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS vers...
  • Modelo / Serial
    Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication system)ARTG Number: 191068
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia