Events

Rappel de Heron Toilet and Bath Chair

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par R82 AU 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-2017-RN-00858-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-11
  • 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-2017-RN-00858-1
  • 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
    R82 australia has been informed about breakage of the aluminium gas spring head for the tilting mechanism on the heron. this particular part was changed to a stainless steel version as of january 2016 and replacement kits are to be provided for replacement on units that still have the aluminium version to eliminate the risk of other breakages.
  • Action
    R82 is undertaking a voluntary measure of sending out stainless steel kits to replace the aluminium units to eliminate the risk of breakages and the potential for related injury. Affected customers are asked to follow the instructions in the customer letter to obtain the new kits.

Device

Heron Toilet and Bath Chair
  • Modèle / numéro de série
    Heron Toilet and Bath Chair Article Numbers: 880505-01 and 880505-11Manufactured between 23rd October 2013 to the 16th December 2015ARTG Number: 229744
  • Manufacturer
    R82 AU Pty Ltd

Manufacturer

R82 AU Pty Ltd