Events

Retiro De Equipo (Recall) de LED Single Bay Battery Charger, supplied with LED Headlight System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-00760-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-08
  • 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-00760-1
  • 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
    Integra neurosciences has been notified by the manufacturer that they have identified through an investigation of complaints that some lot numbers of the integra led single bay battery charger may prematurely fail and will not charge the integra led battery as intended. also, there were isolated complaints that sparks were observed due to pc board components not meeting their specification requirements.
  • Acción
    Customers are asked to review their Integra LED battery charger inventory. Integra will issue replacements, if customers have the affected battery chargers.

Device

LED Single Bay Battery Charger, supplied with LED Headlight System
  • Modelo / Serial
    LED Single Bay Battery Charger, supplied with LED Headlight SystemCatalogue numbers: 90523 (battery charger); 90520AU (LED Headlight system)Lot numbers: IE123610, IE123710, IE123810, IE123910, IE124010, IE124110, IE124210, IE124310, IE124410, IE124510, IE124610, IE124710, IE124810, IE124910, IE125010, IE125110, IE125210, IE130110, IE130210, IE130310, IE130410, IE130510, IE130610, IE130710, IE130810, IE130910, IE131010ARTG number: 194313 (Battery Charger) /188571 (Headlight System)
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd