Events

Rappel de Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand

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-01285-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-04
  • 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-01285-1
  • 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 were three incidents (one in australia and two in the united states) where the wall stand (bucky) continued its downward movement despite the radiographer/operator releasing the motorised wall stand (ws) keypad button which controls the downward movement. this can result in the wall stand contacting a patient's legs or feet.
  • Action
    Carestream Australia is conducting a field action to apply a label to remind users of the location of the emergency stop button and to inspect and install a bracing bracket for the motorised wall stand (bucky) keypad or replace keypad if deemed necessary by Carestream's service engineer.

Device

Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream ...
  • Modèle / numéro de série
    Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall StandSerial numbers: 4000 – 5160 and 75000103 - 75000944ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd