Events

Rappel de Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)

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-2013-RN-01075-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • 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-2013-RN-01075-1
  • 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
    Investigations have shown that the overheating protection system of the heating element may fail to function under certain circumstances. this could result in a burn or respiratory complications as a result of inhaling smoke. the reported overheating events have been confined to the machines. therefore, the probability of occurrence of harm to person based on available evidence is considered remote.
  • Action
    Getinge is advising customers that a customer service representative will be contacting users to replace the affected overheating protective system. Given the low probability to harm, Getinge is advising that it is considered safe for a normal user who services and uses the machine as intended to continue using the machines while waiting for replacement.

Device

Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination ...
  • Modèle / numéro de série
    Getinge 46-Series Washer Disinfector with PACS 300 module(used for the cleaning, decontamination and disinfecting (by heat) reusable surgical instruments, anaesthesia equipment, shoes and other operational utensils)Manufactured between 2004 and 2008ARTG Number: 125655
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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