Events

Retiro De Equipo (Recall) de Getinge VOLISTA StandOP and TRIPOD surgical lights

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-2018-RN-00282-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-27
  • 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-2018-RN-00282-1
  • 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
    Getinge has identified an issue causing failure of the control keypad resulting in the cupola not turning on or off. a review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. this potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. the keypads at fault are no longer produced. getinge have implemented a more robust keypad using a different technology. this action is to replace the potentially defective keypads with the new keypad.To date, no injuries as a result of this issue have been reported.
  • Acción
    Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad.

Device

Getinge VOLISTA StandOP and TRIPOD surgical lights
  • Modelo / Serial
    Getinge VOLISTA StandOP and TRIPOD surgical lights Model Codes: VOLISTA 400 and VOLISTA 600Manufactured before June 2017Keypad Part Number: ARD568801560Up to Serial Number: 540000Device Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960, ARD568821963, ARD568822960, ARD568822963ARTG Number: 162037(Getinge Australia - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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