Events

Rappel de Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus 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-00859-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-00859-1
  • 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
    The power switch of the abovementioned models may become stuck after extended use and the following may occur: 1) when the power switch is stuck whilst the unit is ‘on’, the unit cannot be turned ‘off’ using the power switch on the model. 2) when the power switch is stuck whilst the unit is ‘off’, the unit cannot be turned ‘on’ using the power switch on the unit. this issue could result in a delay of diagnosis or treatment procedure as the device would no longer be operational a replacement device would be needed to complete treatment or diagnosis.
  • Action
    An Olympus Field Service Technician will replace the power switch on all the affected units. This action has been closed-out on 18/07/2016.

Device

Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon ...
  • Modèle / numéro de série
    Processor HDTV Visera Elite, Processor HDTV Exera III, 3d Visualization Unit, Light Source Xenon Visera Elite, Light Source Xenon Exera III, High Flow Co2 Insufflator, Scopeguide Unit & Video System Center (components or parts of endoscopes)Model Numbers: OTV-S190, CV-190, 3DV-190, CLV-S190, CLV-190, UHI-4, UPD-3 & CV-170ARTG Numbers: 120819, 120820, 194240, 211802, 219880 & 216644
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd