Events

Rappel de Revolution CT Scanners, software version 15MW03.12

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-01058-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-28
  • 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-2015-RN-01058-1
  • 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
    A potential hazardous situation can occur during a routine head scan with possible artefacts that may emulate pathology between the brain tissue and bone in the head images. no injuries have been reported to date related to this issue.
  • Action
    To minimise the effects of beam hardening artefacts during routine head scans, GE Healthcare recommends that in addition to the information in the existing CT User Manual, the site also follow the additional recommendations identified in the customer letter. GE Healthcare will be delivering an addendum to the User Manual that reiterates these mitigations. Additional improvements to image quality are currently in development. This software will be distributed and installed on affected systems. This action has been closed-out on 29/08/2016.

Device

Revolution CT Scanners, software version 15MW03.12

Manufacturer

GE Healthcare Australia Pty Ltd