Events

Rappel de YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet 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-01151-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-14
  • 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-01151-1
  • 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
    Maquet has identified a potential issue with the release lever of the screw tension mechanism, whereby it may be difficult to set or maintain the desired traction. this issue can occur during use with any patient population, however it is most likely to occur when setting higher tensions.
  • Action
    A Maquet authorised Service Engineer is to arrange an appointment to assess the affected devices and to replace the release lever. Customers are advised to be aware that they may experience difficulty with the tension mechanism until the repair/replacement activity is performed.

Device

YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)
  • Modèle / numéro de série
    YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)Part Number: 1433.62A1; Serial number: 001-107Part Number: 1433.62A0; All serial numbersARTG Number: 163023
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA