Events

Rappel de Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Vatech Medical Pty Ltd.

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-01219-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-04
  • 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-01219-1
  • 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
    The manufacturer has identified these products as possibly having a faulty coupling spacer. the coupling spacer used during this period was made out of plastic and in some instances the plastic spacer can break. when the coupling spacer is damaged, the column shaft will make a noisy sound when the operator continues to adjust the up/down switch.This recall action was not notified to the tga before it was initiated by vatech medical.
  • Action
    The sponsor is providing users with work around instructions and will be replacing the spacers on all affected devices.

Device

Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ra...
  • Modèle / numéro de série
    Vatech X-Ray System, models: Pax-500, Pax-Uni3D, pax-Reve3D and Duo3D and Picasso 3D (Dental x-ray system)Manufactured between 15 May 2009 and 15 July 2009. ARTG Number: 199091
  • Manufacturer
    Vatech Medical Pty Ltd

Manufacturer

Vatech Medical Pty Ltd