Events

Retiro De Equipo (Recall) de IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2013-RN-00223-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-03-12
  • 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-2013-RN-00223-1
  • 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
    When loading a study to an analysis application while using url pacs integration configuration, after another study was opened by a review application, the analysis monitor is updated with the study of the current patient but the review monitor continues to display the study from the previous patient.
  • Acción
    Philips Healthcare will be installing a software update to address the above identified issue. As a temporary mitigation, the clinicians have been advised that when reviewing two disparate image datasets, not to only be focused on the actual image content but also to be alerted to the patient’s study name and/or ID prior to interpretation.

Device

IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers...
  • Modelo / Serial
    IntelliSpace Portal software version 4.0.2 (Used to remotely access data from networked computers for diagnostic viewing) used with URL PACS integration ARTG Number: 188684
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA