Events

Rappel de VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Getinge Australia 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-2018-RN-00656-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-31
  • 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-00656-1
  • 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
    Getinge has identified that a screw is missing from the racket of the cupola on some devices in production. it is not yet confirmed whether the screw was missed during manufacture or had loosened over the life of the device. as a consequence the light head shaft could break and the cupola could detach itself when manipulated and be held only by its cables. it appears such event is more likely to happen mainly during maintenance, cleaning and surgery preparation.
  • Action
    Getinge are advising they will contact affected sites to plan for update of devices. In the interim, users should verify whether the cupola has mechanical play by following the guidance provided in the Customer Letter. If no play in the cupola is detected the device may continue to be used. If play is detected, users should cease use of the device and contact Getinge immediately.

Device

VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads
  • Modèle / numéro de série
    VOLISTA STANOP, TRIPOD, ACCESS and QUICKLOCK Light heads All units manufactured until December 2016Light Head Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960 and ARD568822960ARTG Number:162037
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA