Events

Rappel de MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas

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-00045-1
  • 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-00045-1
  • 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 received complaints indicating that the central handle holder detaches easily from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. in this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
  • Action
    Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings.

Device

MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas
  • Modèle / numéro de série
    MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD5688112962, ARD568821913,Serial Numbers (up to, for the above part numbers respectively): 50000, 500063, 500003, 500030, 500004, 50000, 500046, 500007, 500001ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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