Events

Rappel de Specular Microscope SP-1P (non-invasive photographic microscope)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-00771-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-10
  • 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-00771-1
  • 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
    It has come to the attention of topcon corporation that during the analysis of large corneal endothelial cells captured by the “specular microscope sp-1p” the unit may provide higher than actual cell count. topcon corporation found that in some cases when an image with large corneal endothelial cells (approximate cell density 1,500 cells/mm2 or less) was analysed the cell density may be higher due to a smaller cell area. consequently, when an image with large corneal endothelial cells is analysed by the current auto-analysis software, it detects the core of the cell as a cell wall, hence one cell would be recognised as two or more cells.
  • Action
    Device Technologies is providing a software upgrade to improve the detection of large size cells. End users are advised to evaluate the examination result of the Specular Microscope SP-1P not only with the resulting cell count, but also by reviewing the captured image while awaiting the software upgrade. This action has been closed-out on 19/02/2016.

Device

Specular Microscope SP-1P (non-invasive photographic microscope)

Manufacturer

Device Technologies Australia Pty Ltd