Events

Rappel de OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010

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-2014-RN-00174-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-20
  • 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-00174-1
  • 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
    Based on post-market surveillance of hardware system performance, it has been identified that system components may cause, in rare situations, a blocking of the magnetic brakes or a system freeze/ system restart during operation potentially prolonging surgery.
  • Action
    Carl Zeiss is providing a software and hardware update to ensure the malfunction does not occur. An enhanced long-term software and hardware maintenance of the OPMI Pentero system procedure is also included in the maintenance package. This action has been closed-out on 28/01/2016

Device

OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, ...
  • Modèle / numéro de série
    OPMI Pentero surgical microscope system (PC 2.1)Manufactured from December 8, 2006 to October 5, 2010Serial Numbers: 6631402471 to 6631461774ARTG Number: 187127
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd