Events

Retiro De Equipo (Recall) de DigitalDiagnost Release 4.0.x (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-2015-RN-00459-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-29
  • 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-2015-RN-00459-1
  • 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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 12 hours, the system will no longer emit this signal.If the system does not provide the expected acoustic signal upon the completion of an exposure, the system operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure.
  • Acción
    Until the system software is upgraded to release 4.0.4 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that the system is rebooted at least every 11 hours. This action has been closed-out on 03/03/2016.

Device

DigitalDiagnost Release 4.0.x (digital x-ray system)

Manufacturer

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