Events

Retiro De Equipo (Recall) de Novacell Battery Charger supplied with the BLS-1000 Light Source set (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-2013-RN-01091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-24
  • 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-2013-RN-01091-1
  • 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
    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.
  • Acción
    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...
  • Modelo / Serial
    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