Events

Rappel de All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare 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-01233-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-12-21
  • 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-2015-RN-01233-1
  • 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
    If the clear patient history prompt is not responded to, the previous patient's weight could be displayed on the giraffe carestation user interface.This could cause clinical decisions to be made based on the weight associated with the wrong patients, which in turn could lead to clinical decisions which could require medical intervention.There have been no injuries reported as a result of this issue.
  • Action
    GE Healthcare is providing work around instructions for users to follow as an interim measure. A software upgrade will be provided as a permanent correction. This action has been closed-out on 29/08/2016.

Device

All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015
  • Modèle / numéro de série
    All Giraffe Carestation Beds shipped between 18 September 2015 and 1 November 2015Giraffe Incubator Carestation Serial Numbers: TAAU67001, TAAU67002, TAAU67003, TAAU67004, TAAU67006, TAAU67007, TAAU67011, TAAU67012Giraffe OmniBed Carestation Serial Numbers: TABU67001, TABU67002, TABU67003, TABU67005, TABU67006, TABU67007, TABU67008, TABU67009, TABU67011 ARTG Number: 139289
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd