Events

Retiro De Equipo (Recall) de MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2017-RN-01394-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-14
  • 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-2017-RN-01394-1
  • 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
    It has been concluded that there is a low failure rate that only can present itself on the devices of types and production identified in this letter. the issue relates to a crack in the metal of the spring arms that has the potential develop into a break. this potential for malfunction is caused by fissures near the weld seam at the front pivot of the spring arm. the design of the spring arm was improved in 2006. the devices are over ten years old and even so the vast majority have not failed. there have been related complaints, however to date no events involving injury have been reported.
  • Acción
    Getinge is advising users that all potentially affected spring arms will be replaced with new spring arms.

Device

MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL ...
  • Modelo / Serial
    MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)Multiple part numbers affectedARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA