Events

Rappel de Getinge 46-Series Washer Disinfector with PACS 300/350

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-2015-RN-00174-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-12
  • 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-2015-RN-00174-1
  • 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
    The manufacturer has received complaints in germany regarding sediment residuals in the manifold of the washer and disinfector of getinge 46-series (cm302) with pacs 300/350 control.The potential risk is that during the drying phase the air circulating may transport particles from the sedimentation and deposit it on goods. if the particle contains bacterial flora there is the risk of cross contamination.The problem has been identified as insufficient water flow throughout the manifold due to formation of air-pockets where sedimentation may occur. the use of detergents that are not recommended might also have negative impact.No serious injury has been reported in any of the known cases.
  • Action
    Getinge will contact customers to carry out a modification that will permanently mitigate the risk of this issue occurring in the future. In the interim customers are advised to perform a visual check of all washed items after removal from the washer. Items should be re-washed if any particles are observed. This action has been closed-out on 1/06/2016.

Device

Getinge 46-Series Washer Disinfector with PACS 300/350

Manufacturer

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