Events

Rappel de Getinge HS33 Sterilsers

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-2017-RN-00251-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-28
  • 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-00251-1
  • 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 has identified an issue with getinge hs33 manual door sterilisers, which can potentially cause the door with manual mechanism to unseal during the process. this can cause potential steam leakage. this potential for malfunction is caused by the design of the door hook which is a part of the door locking mechanism (part number 4839900). when the door has been closed and the sterilisation process has started, the leak may occur through the door gap, however the door will not slide down as the clamping brakes located on both sides of the door hinder the slide down. in case the process must be interrupted due to safety reasons, the emergency stop button will immediately cut off steam supply to the chamber. getinge's investigation which included risk analysis and evaluation of the worst-case scenario concluded that it is highly unlikely the malfunction would cause or contribute to an injury.
  • Action
    Getinge has developed a new design of the component (part no 6011000223) to prevent device door to unseal during the process. This action is to replace the existing door hook (part no 4839900) with the new and corrected design.

Device

Getinge HS33 Sterilsers
  • Modèle / numéro de série
    Getinge HS33 SterilsersModel Numbers: 978053XXX, 978055XXX and 6011978043XXXSerial Numbers: 11101581, 12031135, 12171741, 12481961, 13122119, 13402211, 13412218, 13412224, 13452238, 14483126ARTG Number: 275198
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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