Events

Rappel de Lights - Ardon

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Maquet SA.

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
    23048
  • Date de mise en oeuvre de l'événement
    2018-05-29
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • Cause
    The manufacturer has identified that an issue might prevent the device from performing as intended. it was established that, with some of the manufactured units, a screw is missing on the racket of the cupola on some devices in production or that the screws have loosened over the course of life. 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
    Product to be modified

Device

Lights - Ardon
  • Modèle / numéro de série
    Model: Part number - ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962,ARD568821913, ARD568821960, ARD568822960, Affected:
  • Manufacturer
    Maquet SA

Manufacturer

Maquet SA
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    NZMMDSA