Events

Retiro De Equipo (Recall) de A-dec 200 Dental Chair (examination chair)

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-2012-RN-01114-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-15
  • 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-2012-RN-01114-1
  • 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
    Preliminary analysis indicates that several lots of mounting bolts were subjected to plating conditions that may have contributed to hydrogen embrittlement, which in turn could cause mounting bolt failure. it was also determined that in addition to mounting bolts for the support centre that mounting bolts for the upper structure attachment to the chair base could also have been subjected to plating conditions that may have contributed to hydrogen embrittlement.This recall action was not notified to the tga before it was initiated by a-dec australia.
  • Acción
    The sponsor is advising users that the dealer will be replacing the four support centre bolts.

Device

A-dec 200 Dental Chair (examination chair)
  • Modelo / Serial
    A-dec 200 Dental Chair (examination chair)All batches/serial numbers manufactured since March 2011ARTG Number: 118326
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA