Events

Rappel de VisuMax Laser

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-2017-RN-00318-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-06
  • 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-2017-RN-00318-1
  • 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 complaints, carl zeiss has identified that in certain devices there is an increased probability of failure of the battery test circuit components of the uninterrupted power supply (ups)-module. it was reported from customers that after treatment was done and machine was switched off white smoke with choking smell came out from the ups at the rear side of the machine. there were no patient involvement and no adverse consequences associated with these complaints.
  • Action
    The battery circuit for the UPS has been modified to make the UPS more robust. Carl Zeiss will replace all old power supplies as part of the next scheduled service activities of the VisuMax.

Device

VisuMax Laser
  • Modèle / numéro de série
    VisuMax LaserSerial numbers starting with 963599 up to 1157772ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd