Events

Rappel de DRX Revolution Mobile X-Ray System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carestream Health 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-01269-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-09
  • 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-01269-1
  • 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, carestream health inc has received reports of the below incidents:- in the usa, the end cover of the drx revolution mobile x-ray system column was dislodged when it was caught on an interfering object whilst the column was descending.- four occurrences in the usa of a communication failure between pc (host computer) and communication i/o board (cib) resulting in the generator not being reset after a successful exposure and image acquisition. this resulted in an exposure initiated by the user using the hand switch completing without the image being captured.
  • Action
    Carestream Health is installing a replacement end cap and software update to correct the issues.

Device

DRX Revolution Mobile X-Ray System

Manufacturer

Carestream Health Australia Pty Ltd