Events

Rappel de Patient Support (NC989001087431) for X-Ray System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00881-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-02
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00881-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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”.
  • Action
    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
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA