Events

Rappel de LumaDent Light Battery Charger

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-2016-RN-00746-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-03
  • 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-2016-RN-00746-1
  • 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
    Carl zeiss pty ltd, following advice from lumadent is replacing the battery charger of the lumadent light. this applies to all charger model numbers, except model number sw-084120. model number sw-084120, which is the only correct model for all lumadent batteries bp500 (v3.1, v3.2 and v3.3), is not affected by this recall. the affected battery chargers have not been demonstrated to comply with australian and new zealand electrical safety standards thus may have the potential to overcharge the batteries causing them to overheat and catch fire. there have been no reports of injuries as a result of this issue.
  • Action
    Carl Zeiss are advising users to inspect all battery chargers and quarantine any batteries which are not model number SW-084120. Carl Zeiss will replace any affected stock. This action has been closed-out on 02/03/2017.

Device

LumaDent Light Battery Charger
  • Modèle / numéro de série
    LumaDent Light Battery Charger All model numbers affected EXCEPT SW-084120ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd