Events

Retiro De Equipo (Recall) de LumaDent Light Battery Packs

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Carl Zeiss 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-01248-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-27
  • 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-01248-1
  • 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
    Carl zeiss pty ltd, following advice from lumadent inc (manufacturer of the lumadent light) is replacing the battery packs of the lumadent light for battery packs with a serial number starting with bp0114. the affected battery packs may have a fault that has the potential to cause the batteries to overheat and catch fire.
  • Acción
    Customers are asked to inspect their battery packs and quarantine all affected units for recovery and replacement with unaffected stock. This action has been closed-out on 07/07/2016.

Device

LumaDent Light Battery Packs
  • Modelo / Serial
    LumaDent Light Battery PacksBBatch numbers starting with BP0114ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd