Events

Rappel de Getinge VOLISTA StandOP and TRIPOD surgical lights

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-00282-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-27
  • 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-00282-1
  • 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 an issue causing failure of the control keypad resulting in the cupola not turning on or off. a review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. this potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. the keypads at fault are no longer produced. getinge have implemented a more robust keypad using a different technology. this action is to replace the potentially defective keypads with the new keypad.To date, no injuries as a result of this issue have been reported.
  • Action
    Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad.

Device

Getinge VOLISTA StandOP and TRIPOD surgical lights
  • Modèle / numéro de série
    Getinge VOLISTA StandOP and TRIPOD surgical lights Model Codes: VOLISTA 400 and VOLISTA 600Manufactured before June 2017Keypad Part Number: ARD568801560Up to Serial Number: 540000Device Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960, ARD568821963, ARD568822960, ARD568822963ARTG Number: 162037(Getinge Australia - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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