Events

Retiro De Equipo (Recall) de Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring 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-2014-RN-00349-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-20
  • 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-2014-RN-00349-1
  • 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
    Continuous use of the ip5 for more than 24 days, without power cycling, results in a graphical user interface (display screen) error, which causes the numeric data on the display to freeze and disables some menu keys. waveform data displayed and audible alarms are not impacted by this problem and continue to function properly.
  • Acción
    Philips is advising end users to ensure that the IP5 is power cycled every 24 hours. A correction is being investigated and will be provided once available.

Device

Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient mo...
  • Modelo / Serial
    Expression Information Portal - IP5 (secondary display control unit for Expression MRI patient monitoring system)Product Code: 865471Service Number: 453564251511Serial Numbers: US23200375, US23200376 and US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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