Events

Retiro De Equipo (Recall) de LumaDent Light Battery Charger

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-2016-RN-00746-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-03
  • 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-2016-RN-00746-1
  • 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 is replacing the battery charger of the lumadent light. this applies to all charger model numbers, except model number sw-084120. model number sw-084120, which is the only correct model for all lumadent batteries bp500 (v3.1, v3.2 and v3.3), is not affected by this recall. the affected battery chargers have not been demonstrated to comply with australian and new zealand electrical safety standards thus may have the potential to overcharge the batteries causing them to overheat and catch fire. there have been no reports of injuries as a result of this issue.
  • Acción
    Carl Zeiss are advising users to inspect all battery chargers and quarantine any batteries which are not model number SW-084120. Carl Zeiss will replace any affected stock. This action has been closed-out on 02/03/2017.

Device

LumaDent Light Battery Charger
  • Modelo / Serial
    LumaDent Light Battery Charger All model numbers affected EXCEPT SW-084120ARTG Number: 207981
  • Manufacturer
    Carl Zeiss Pty Ltd

Manufacturer

Carl Zeiss Pty Ltd