Events

Retiro De Equipo (Recall) de IntelliSpace PACS 4.4 (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-2013-RN-01072-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-17
  • 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-01072-1
  • 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
    Philips healthcare has become aware of a potential problem with the philips intellispace pacs system. there is a software issue which in certain circumstances could result in the unintended deletion of images sent to the intellispace pacs 4.4 before they are available for access by system users. timing of images being received by the pacs varies based on study size or modality configuration. if additional images are received into the study input folder as the input folder is being deleted, those images are not saved and can result in missing images.
  • Acción
    Philips is providing temporary workaround instructions to mitigate the failure mode occurring. Philips is developing a software update that corrects this issue. It is anticipated this update will be available before the end of October 2013.

Device

IntelliSpace PACS 4.4 (Picture archiving and communication system)

Manufacturer

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