Events

Rappel de Slit Lamp

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-01150-1
  • 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-01150-1
  • 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 determined that in certain devices there is an increased probability of failure of the power supply on/off switch, and surface corrosion of the mirror which changes the direction of the light projection. there is no potential health hazard and the probability of injury is extremely unlikely. in a worst case scenario, a burning smell may result from a thermal event at the power supply on/off switch. issues associated with the surface corrosion of the mirror may lead to inadequate mirror function. the slit projection may be slightly darker and more diffused.
  • Action
    Replace the affected power supply and mirror. Carl Zeiss service staff will arrange an appointment for the replacement of the power supply and the mirror of your slit lamp SL 220.

Device

Slit Lamp
  • Modèle / numéro de série
    Slit LampModel Number: SL 220 Serial Numbers: 970712XXXX and 970714XXXXARTG Number: 94353
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd