Events

Rappel de Kodak DirectView DR 7500 (Diagnostic 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-2014-RN-00839-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-31
  • 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-2014-RN-00839-1
  • 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
    Carestream health australia pty ltd has received advice that there was an incident overseas where the beta assembly (x-ray tube and collimator) detached from the overhead tube crane (otc) telescope, falling onto the patient who was injured, requiring hospitalisation. no other reports of this type have been received since the device was introduced into commercial distribution in 2005. carestream health has determined that this incident occurred due to the part that holds the beta assembly to the otc telescope not being properly assembled at the time of manufacture.
  • Action
    Carestream Health Australia Pty Ltd is arranging for inspection of all the affected units and will conduct a repair if required. This action has been closed-out on 19/02/2016.

Device

Kodak DirectView DR 7500 (Diagnostic x-ray system)

Manufacturer

Carestream Health Australia Pty Ltd