Events

Rappel de CS 8100 & CS 8100 3D (A diagnostic dental 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-2015-RN-00073-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-29
  • 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-00073-1
  • 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 a report that the column of a cs 8100 demonstration device descended unexpectedly as one of the two retaining clips (circlips) that holds the locating pin in place was missing. if a circlip is not placed on both ends of the locating pin, it is possible that movement and transport of a unit can cause the pin to move out of position, or fall out completely. testing showed the device operation could appear normal for several lifting cycles after the pin fell out completely due to friction holding the ends of two units together, but the jack would eventually slip off the base plate stand. no other reports, complaints or injuries of this type (related to missing circlip) have been received since the device was introduced into commercial distribution in 2012.
  • Action
    Carestream Health Australia is organising a service call and a service engineer will attend the user’s site, make a detailed inspection and replace the column assembly if required. This action has been closed-out on 24/05/2016.

Device

CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)
  • Modèle / numéro de série
    CS 8100 & CS 8100 3D (A diagnostic dental x-ray system)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.Manufacturing Date: June 2012 to September 2014ARTG Number: 136114 and 136106
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd