Events

Retiro De Equipo (Recall) de FORUM Software

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

¿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-2015-RN-00051-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-22
  • 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-2015-RN-00051-1
  • 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
    Forum is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. it is intended to work with other forum applications.Forum correctly displays the optical coherence tomogram (oct) retinal b-scan when initially rendered, but a different b-scan tomogram is potentially displayed on subsequent renderings within a user session.Therefore, in certain circumstances an incorrect oct retinal b-scan tomogram scan may be displayed when retrospectively reviewing the available scans.This gives rise to a risk of a healthcare professional making a medical decision for the patient after viewing the wrong scan to what they requested.No incidents have been reported in australia or new zealand.
  • Acción
    An initial workaround is provided to users in the Customer Letter whilst a permanent Software fix is being developed for rollout in February 2015. This action has been closed-out on 18/07/2016.

Device

FORUM Software

Manufacturer

Carl Zeiss Pty Ltd