Events

Retiro De Equipo (Recall) de A-dec 311 Chair and A-dec 361 Support Centre

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por A-DEC Australia.

¿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-2013-RN-00380-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-07
  • 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-2013-RN-00380-1
  • 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 strength of some screws (or "fasteners") may have been compromised due to a plating process issue. under certain circumstances, the fasteners can become brittle, which might lead to a chair and/or delivery system instability.
  • Acción
    The sponsor is advising their customers that the dealer will be replacing the fasteners with screws unaffected by hydrogen embrittlement.

Device

A-dec 311 Chair and A-dec 361 Support Centre
  • Modelo / Serial
    A-dec 311 Chair and A-dec 361 Support CentreA-dec 311 ChairARTG Number: 118326A-dec 361 Support CentreARTG Number: 118333 Multiple Serial Numbers (see attached)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA