Events

Retiro De Equipo (Recall) de MobileDiagnost wDR 2, all software versions affected (diagnostic 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-2016-RN-00595-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-05-06
  • 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-2016-RN-00595-1
  • 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
    During recent evaluations of the philips mobilediagnost wdr 2, philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions. 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “normal”), even though the patient type “newborn” was selected and is displayed in the generator control area of the eleva user interface.2. under certain conditions, the detector might not be ready for examination. released x-ray might lead to an image with artefacts and a retake is required. while the attachment process is running, the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
  • Acción
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

Device

MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)
  • Modelo / Serial
    MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system)All systems affectedARTG Number: 187112
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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