Events

Rappel de Novacell Battery Charger supplied with the BLS-1000 Light Source set (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-2013-RN-01091-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-24
  • 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-2013-RN-01091-1
  • 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
    Ashmed has been made aware of the potential for over-heating and possible burning or bursting of lithium-ion batteries with the affected vision sciences battery charger model. when the battery is unintentionally placed by the user in a reversed polarity position for charging, the anode pin on the charger may come into contact with the negative polarity of the battery causing overheating.
  • Action
    AshMed Pty Ltd is requesting their customer to inspect their Vision Sciences battery charger to determine if they are affected by the issue. Affected units are to be immediately quarantined. AshMed Pty Ltd will arrange for replacement with unaffected chargers.

Device

Novacell Battery Charger supplied with the BLS-1000 Light Source set (light source for endoscopic...
  • Modèle / numéro de série
    Novacell Battery Charger supplied with the BLS-1000 Light Source set (light source for endoscopic procedures)Model number of battery charger: NV-LC02
  • Manufacturer
    Vision Sciences Australia Pty Ltd

Manufacturer

Vision Sciences Australia Pty Ltd
  • Source
    DHTGA