Events

Rappel de A-dec 200 Dental Chair (examination chair)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par A-DEC Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-01114-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01114-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    The sponsor is advising users that the dealer will be replacing the four support centre bolts.

Device

A-dec 200 Dental Chair (examination chair)
  • Modèle / numéro de série
    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