Events

Rappel de i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par IQ Medical.

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-01265-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-04
  • 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-2014-RN-01265-1
  • 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
    After upgrading the cassini software to version 2.0.0, the cassini patient database may have beencompromised, resulting in patient examination data being linked to the wrong patient.
  • Action
    Technical support representative will contact affected customers to inspect and, if necessary, to correct the issue. During the restoration process, the Cassini device will be locked and cannot be used. This is estimated to take 1 to 3 hours. Until the database integrity has been ensured, users are advised not to use patient examination data unless verified to be correctly associated with the patient. A software patch is under development (version 2.0.1, expected mid-December) including making a back-up before updating and a database check before and after an update. This action was undertaken prior to consultation with the Therapeutic Goods Administration. This action has been closed out on 29/01/2016.

Device

i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0
  • Modèle / numéro de série
    i-Optics’ Cassini, Corneal Topographer, with a recent software upgrade to version 2.0.0ARTG Number: 219343 (TBC)
  • Manufacturer
    IQ Medical

Manufacturer

IQ Medical