Events

Retiro De Equipo (Recall) de DigitalDiagnost (Digital 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-2012-RN-01224-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-07
  • 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-01224-1
  • 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 previously notified owners of digitaldiagnost systems with software releases 3.0.1 and 3.0.2, that a new software release 3.0.3 would be installed on their systems (without due consultation with the tga). however, software release 3.0.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side of an image is rotated. software release 3.0.4 corrects this defect in release 3.0.3, and it will be installed on affected systems in place of release 3.0.3.When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. when the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
  • Acción
    Update to system software

Device

DigitalDiagnost (Digital diagnostic X-Ray System).
  • Modelo / Serial
    DigitalDiagnost (Digital diagnostic X-Ray System). All systems with Eleva software version 3.0.xARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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