Events

Retiro De Equipo (Recall) de Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic 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-00890-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-04
  • 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-00890-1
  • 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 patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. this can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the unload foot switch. this can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released.
  • Acción
    Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch.

Device

Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (...
  • Modelo / Serial
    Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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