Events

Rappel de Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. (Light Source for endoscopic procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Vision Sciences Australia 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-00930-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-03
  • 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-2014-RN-00930-1
  • 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
    Vision-sciences received a limited number of reports relating to over-heating and possible burning of the lithium-ion batteries being charged with the vision-sciences battery charger. as a precautionary measure vision-science has initiated a recall action, to retrieve all battery charges and dispose of the rechargeable batteries. endoscopes or light sources are not affected by this recall. ashmed pty ltd is the current sponsor and distributor for the vision sciences inc range of endoscopes and accessories in australia and new zealand.
  • Action
    AshMed Pty Ltd is requesting their customer to immediately remove Vanson V-95 Battery Charger from use and mail the affected charger/device to AshMed Pty Ltd, and dispose of rechargeable batteries as per the local regulations. AshMed Pty Ltd and Vision Sciences Inc will supply replacement disposable batteries for the BLS-1000 unit until a permanent replacement that will meet appropriate standards of quality and safety is found.

Device

Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied wit...
  • Modèle / numéro de série
    Vision Sciences Battery Charger (VANSON V-95) and rechargeable Lithium-Ion Batteries supplied with BLS-1000 portable LED light source kits or as standalone items. (Light Source for endoscopic procedures)Catalogue Numbers:BLS-1000 kit (battery & charger) - 07-3053-AUSCharger - 07-3058-AUSLithium-Ion Batteries - 07-3059ARTG Number: 137738
  • Manufacturer
    Vision Sciences Australia Pty Ltd

Manufacturer

Vision Sciences Australia Pty Ltd
  • Source
    DHTGA