Events

Rappel de Sirona Dac Universal Combination Steriliser

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Sirona Dental Systems 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-2016-RN-00771-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-20
  • 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-2016-RN-00771-1
  • 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
    Dac universal mkiii units may have been repaired using spare parts intended for mkii units. there is the possibility of 12mm screws being used as a replacement for the original 16mm screws in the lid holder assembly. in the case, where the incorrect screws are fitted the lid could possibly become unmounted from the unit during its operation. there is a risk that people standing nearby could be harmed if hit by a released lid.
  • Action
    Sirona is advising users to discontinue use of the affected machines until a service technician has inspected and corrected the machine, where required. Users are reminded to continue to manually clean and lubricate the instruments using T1 spray. This action has been closed out on 15 June 2017.

Device

Sirona Dac Universal Combination Steriliser
  • Modèle / numéro de série
    Sirona Dac Universal Combination SteriliserSerial Number Range: 104000-199999, 202000-999999, B14000-B99999, B104000-B199999, B202000-B999999ARTG Number: 197032
  • Manufacturer
    Sirona Dental Systems Pty Ltd

Manufacturer

Sirona Dental Systems Pty Ltd