Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Vision Sciences Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00930-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00930-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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