Events

Retiro De Equipo (Recall) de iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring 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 Trumpf Med Aust 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-00458-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-22
  • 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-00458-1
  • 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
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds of spring arms over time when subject to extreme forces. there is a risk the monitor could fall and swing freely on the swing arm and strike a person or object. there have been no reports of injuries as a result of this issue.
  • Acción
    Trumpf Medical is advising users that if the systems are due for biennial maintenance, to contact the authorised service provider to schedule the preventative maintenance. If the biennial maintenance is not due, and the service provider did not inspect the welds during the previous maintenance, contact the service provider to schedule a service call to inspect the welds. Requirements to inspect the welds during biennial maintenance can be found in the User Manual.

Device

iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Came...
  • Modelo / Serial
    iLED 3/5, TruLight 3000/5000, Helion, TruVidia SD, TruVidia HD, VidiaPort Surgical Lighting, Camera and Monitoring Systems All Serial Numbers affectedARTG Numbers: 200921, 200946, 200943, 200945,170219, 170545
  • Manufacturer
    Trumpf Med Aust Pty Ltd

Manufacturer

Trumpf Med Aust Pty Ltd