Events

Rappel de CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Carl Zeiss 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-2018-RN-00350-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-27
  • 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-2018-RN-00350-1
  • 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 been identified that it is possible for the clarus 500 to allocate patient data to the wrong patient. this may occur when the operator exits the acquire page to the patient management page while the system is in process of creating the montage of two or more images. the constituent images from which the montage is derived are still assigned to the correct patient. they can be viewed individually or manually montaged to recreate the missing information. the error is detectable as there will be no constituent image to support the montage for the affected patient.
  • Action
    Zeiss will be conducting a software update by the ZEISS Service Centre and important changes to the User Manual for CLARUS 500 which has already been supplied to users. A software update is available for the CLARUS 500 and updated user manual is available accordingly. The update only applies to CLARUS 500 devices with software versions 1.0.0, 1.0.1, and 1.0.2.

Device

CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2
  • Modèle / numéro de série
    CLARUS 500 with Software versions: 1.0.0, 1.0.1 and 1.0.2ARTG Number: 295240Carl Zeiss - Camera, fundus
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd