Events

Rappel de VisuMax

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-01144-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-09-04
  • 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-2017-RN-01144-1
  • 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 activities, carl zeiss has received information that in certain devices there is an increased probability of failure of the bpc board. the function of this board is to control an electrically driven mirror which adjusts the laser beam position if necessary. this design allows a position compensation in case the laser beam should drift.It has been determined that there was a deviation in the soldering process during the manufacture of two batches of the bpc board which can affect the reliability of the visumax beam pointing control subsystem.The probability of injury is extremely unlikely. any failure of the bpc board like error 0x3172 is detected by the monitoring functions of the device either during startup or before start of a treatment. in case of a system error the system test is cancelled before any treatment. if an error occurs, the device goes in a safe mode.
  • Action
    Complete and return the supplied acknowledgement form. Carl Zeiss service staff will contact users to arrange an appointment for the BPC Board exchange.

Device

VisuMax
  • Modèle / numéro de série
    VisuMaxCatalogue Number: VISMAXSerial Number: 1173839ARTG Number: 150527
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd