Events

Retiro De Equipo (Recall) de IntelliSpace PACS 4.4 (Radiology 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 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-2014-RN-00952-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-02
  • 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-2014-RN-00952-1
  • 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
    In philips intellispace pacs 4.4, there is feature which allows the optional configuration of auto export of resolved study exception immediately after resolution. when this configuration is used, it is possible for a system timing issue to occur when exporting data to 3rd party devices. if this system timing issue occurs when demographics are updated, such as during exception resolution and the study is immediately exported, the patient demographic information can be incorrect in the exported data. although the data is correct in intellispace pacs if diagnosis is performed on this exported data using a 3rd party device the user may not be aware of unchanged patient data is being utilised. if this were to occur diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient. the hazard involved is that diagnosis may be based on an incomplete set of images, or images that are associated with the wrong patient.
  • Acción
    Each site will be contacted by Philip’s Technical Account Manager and notified if Auto Export is configured at the site and to schedule either the disabling or the correction of the Auto Export Feature. Determined by site utilization of the feature, Philips will schedule and deploy software correction or will disable the Auto Export Feature for all IntelliSpace 4.4 installations impacted by this issue. This action has been closed-out on 17/08/2016.

Device

IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)
  • Modelo / Serial
    IntelliSpace PACS 4.4 (Radiology picture archiving and communication system)All versions of IntelliSpace PACS 4.4 with Auto Export Feature Enabled are affectedARTG Number: 178437
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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