Events

Retiro De Equipo (Recall) de Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems

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-00120-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-07
  • 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-00120-1
  • 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
    The manufacturer, getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. the observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. only one (i.E. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
  • Acción
    Getinge is advising users that a service technician will be correcting all affected units.

Device

Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems
  • Modelo / Serial
    Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting SystemsManufactured between August 2009 and July 2014Multiple Part Numbers affected ARTG 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