Events

Retiro De Equipo (Recall) de Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)

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-01183-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-09-13
  • 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-01183-1
  • 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 has been notified regarding an issue with the x-ray "on" label for systems supplied in south australia. the colour of the exposure indicator on the control panel is same as the background text. hence, systems do not meet south australia's radiation protection and control regulation.This issue has been evaluated for radiation hazard and concluded that there is no safety impact to the patient, user or bystander. it is a regulatory non-compliance issue in south australia. this issue has been evaluated for potential radiation hazard and concluded that there is no safety impact to the patient, user or bystander.
  • Acción
    Philips will be applying a red transparent label over the existing x-ray symbol on the control panel as a permanent correction in the affected systems in South Australia. In the interim, users are advised that there is an indicator lamp on Mobile Viewing Station which glows whenever x-ray exposure happens. The user should use this indication to be able to know when an exposure happens. This action has been closed-out on 24/05/2017.

Device

Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)
  • Modelo / Serial
    Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)System: BV25Model Number: 718015System: BV300Model Numbers: 71815, 71816, 71819System: BV LibraModel Numbers: 718022, 718030, 718031System: BV EnduraModel Numbers: 718071, 718072, 718073, 718074System: BV PulseraModel Number: 718094ARTG Number: 98556
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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