Events

Retiro De Equipo (Recall) de MobileDiagnost wDR (digital diagnostic X-ray imaging 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-2012-RN-01277-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-18
  • 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-2012-RN-01277-1
  • 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 the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position on the resulting image. electronic patient side (left / right) markers on wrong image.
  • Acción
    As an interim measure, Philips is advising users to manually rotate an image with the rotation tool and to use a L/R lead marker to mark the patient side permanently in the image instead of using the automatic L/R markers from the EPX-database. Philips will implement a software update to solve this issue.

Device

MobileDiagnost wDR (digital diagnostic X-ray imaging system)
  • Modelo / Serial
    MobileDiagnost wDR (digital diagnostic X-ray imaging system)All MobileDiagnost wDR except USARTG number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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