Events

Rappel de W & H Foot Control - S-N1/S-N2

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-2018-RN-00006-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-16
  • 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-2018-RN-00006-1
  • 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
    A-dec has been made aware of a potential malfunction with certain w&h; foot controls. the foot control might not switch back to zero position when the pedal is released. consequently, the motor keeps rotating. if this happens during automatic thread cutting or automatic screwing-in of implants, it can, in the worst case, lead to a serious injury of the patient. so far, no incident has been reported.
  • Action
    A-Dec will contact affected customers to arrange replacement foot controls to be provided. In the interim, the affected products must not be used for thread cutting and screwing in of implants. These operations have to be conducted manually.

Device

W & H Foot Control - S-N1/S-N2
  • Modèle / numéro de série
    W & H Foot Control - S-N1/S-N2Multiple Affected Serial NumbersARTG 125363 (ADEC AUSTRALIA - Implantmed (various models) - Drill/saw system, dental)
  • Manufacturer
    A-DEC Australia

Manufacturer

A-DEC Australia
  • Source
    DHTGA