Events

Retiro De Equipo (Recall) de DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray 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-00910-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-28
  • 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-00910-1
  • 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
    The mirror icon on the bottom of each image could be misinterpreted as a right lead marker for side indication if the image is mirrored within a pacs system.The misinterpretation of the mirror icon to be a patient right side indication could potentially lead to a misdiagnosis.
  • Acción
    Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of the patient or equivalent electronic markers to provide Left/Right indicators, during all x-ray image acquisitions. Philips is advising users that a software and hardware upgrade will be performed to replace the mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system.

Device

DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)
  • Modelo / Serial
    DigitalDiagnost - EasyUpgrade DR (Diagnostic digital x-ray system)system code 712086ARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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