Events

Retiro De Equipo (Recall) de Patient Support (NC989001087431) for 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-2018-RN-00881-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-02
  • 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-2018-RN-00881-1
  • 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 footplate of the patient support for stitching can be fixed in upper position. philips has identified that when the fixing clamp (hook) is not in its correct locking position, the footplate is not securely held. if it falls down, it may hurt the operators or patient's foot or leg (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the footplate up). the following factors are needed for this situation to occur:- hinges are worn differently on both sides;- hook does not hold;- the operator does not check that the hook securely holds the footplate;- the footplate falls unexpectedly when touched or during transport;- foot or leg is in the “target area”; and/or- foot is in the “hazard area”.
  • Acción
    Philips is advising that they plan make the following design changes: - Sturdier replacement hinges for floor plate; - Install modified hook for floor plate (adapted to new hinges); and - The brake cylinder below floor plate to minimise kinetic energy. A Philips service engineer will contact impacted customers as soon as the Field Action Kit is available to be implemented. In the interim, users are advised to always ensure the correct positioning of the hook and that it is locked in accordance with the Instructions for Use (press hook down until it is locked).

Device

Patient Support (NC989001087431) for X-Ray System
  • Modelo / Serial
    Patient Support (NC989001087431) for X-Ray SystemARTG Number: 117662(Philips Electronics Australia Ltd - X-ray system, diagnostic, general-purpose, stationary, digital)
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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