Events

Retiro De Equipo (Recall) de Philips EPIQ Ultrasound 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-00453-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-27
  • 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-00453-1
  • 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 fasteners securing the control panel assembly to the base of the philips epiq ultrasound system may loosen over time, which could subsequently lead to the detachment of the entire assembly from the ultrasound system.If the control panel assembly detaches from the ultrasound system and falls, bruising of the operator or other minor injury could result.
  • Acción
    Philips will contact all EPIQ customers to arrange for service to replace the fasteners connecting the control panel assembly to the system with fasteners less likely to loosen with repeated handling. This service will be performed free of charge.

Device

Philips EPIQ Ultrasound System

Manufacturer

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