Events

Rappel de DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital 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-00763-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-21
  • 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-00763-1
  • 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 has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. if there is no use of external fiducial markers or measurement tools (eg. radiopaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors. this may lead to potential diagnosis errors if measurements taken from just that image wererelied on. any injury resulting from this could lead to delays in treatment or the need for further diagnostic imaging techniques.
  • Action
    Whilst there have not been any diagnosis errors reported, Carestream Health is conducting this action to update the software on affected devices to correct this issue. In the interim, Carestream Health recommends that the auto-stitching feature is turned off and the manual stitch editor used to create all composite images until the software update has been made to affected devices. This action has been closed-out on 12/08/2016.

Device

DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolutio...
  • Modèle / numéro de série
    DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands(Digital X-ray system)ARTG number: 136112
  • Manufacturer
    Carestream Health Australia Pty Ltd

Manufacturer

Carestream Health Australia Pty Ltd