Events

Rappel de Emergency Room Examination Table

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge 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-2018-RN-00653-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-06-05
  • 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-00653-1
  • 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
    Getinge have received reports where the screws holding the reclining surface on the frame have loosened or completely fallen out. the screws that hold the reclining surface on the frame are not secured against unintentional loosening and the tables may experience this issue with daily use over a number of years. if all screws loosen / become detached and this goes unnoticed, the reclining surface of the table may detach resulting in injury to a patient or operator as a result of falling. to date, no reports of patient injury have been received relating to this issue.
  • Action
    Getinge are advising they will be in contact with impacted users to replace the screws on the table with new screws secured with detent edge discs.

Device

Emergency Room Examination Table
  • Modèle / numéro de série
    Emergency Room Examination Table Models: 4203.9602 ARTG number: 163023(Getinge Australia - Table, operation)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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