Events

Rappel de Maquet H LED and PowerLED 700 Ambient Light Modules

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
    16434
  • Date de mise en oeuvre de l'événement
    2014-04-02
  • 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: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Cause
    The ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models, this module is attached to the cupola through a set of 4 fixing tabs, which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. it has been observed by some of our customers that one or several fixing tabs were broken, which led the ambient light module to detach, remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.
  • Action
    Product to be modified

Device

Maquet H LED and PowerLED 700 Ambient Light Modules
  • Modèle / numéro de série
    Model: Models: HLED700, PWD700, Affected: All units manufactured between Dec-2006 and Dec-2012
  • Manufacturer
    Maquet SA

Manufacturer

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