Events

Rappel de Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)

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-00142-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-10
  • 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-00142-1
  • 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 five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°.The failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. should the arm fall, there is a risk of injury by impact to the patient or user.
  • Action
    To address this issue, a service engineer will attend the customer site, make a detailed inspection and install a bracket modification/replacement kit to address the problem. In the interim, customers are recommended to undertake regular inspections of their units to ensure that the arm has not failed. This action has been closed-out on 01/02/2016.

Device

Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)
  • Modèle / numéro de série
    Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray)Serial numbers starting: WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA,XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD.ARTG inclusion number: 136106
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd