Events

Rappel de Prius Hospital Bed

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Prius Healthcare Solutions 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-00381-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • 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-00381-1
  • 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
    Dickson & dickson healthcare have received a corrective action notice from the manufacturer of this bed to replace incorrect product labelling. prius beds manufactured in may 2015 and july 2015 have the incorrect manufacturer details stated on the label. after consultation with tga, dickson & dickson healthcare ltd is performing a recall for product correction to replace affected labels with the correct information.The labels are to be replaced on all beds in order to comply with the essential principles.
  • Action
    Dickson & Dickson Healthcare is arranging replacement of the labels on all affected beds which will display the correct manufacturers details. This action has been closed-out on 03/03/2016.

Device

Prius Hospital Bed

Manufacturer

Prius Healthcare Solutions Pty Ltd