Events

Rappel de Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Otto Bock Australia Pty 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-2012-RN-00669-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-13
  • 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-2012-RN-00669-3
  • 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 tga received an incident report and examined a kidwalk mobility aid, which had failed at the base of the mast. tga’s investigation recommended to reinforce and update three important points in the owner’s manual (instructions for use) for the kidwalk with aluminium mast supplied prior to december 2010:· considerations on re-issue of the kidwalk.· regular inspection and annual service of the kidwalk · the intended purpose of the kidwalk.
  • Action
    Update to the Instructions for Use (IFU).

Device

Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a...
  • Modèle / numéro de série
    Kidwalk Dynamic Mobility System, model number: KW01 (A wheeled support frame intended to assist a disabled child in walking by providing a means of support)Supplied prior to December 2010Model Number: KW01ARTG Number: 175458
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd