Events

Rappel de H LED and PowerLED Ambient Light Modules (Surgical light)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet 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-2014-RN-00347-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-20
  • 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-2014-RN-00347-1
  • 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
    There is a potential risk of failure concerning the fixation of the ambient light module. it has been observed by some of the customers that one or several fixing tabs were broken, which led the 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
    All customers are asked to check if the ambient light module is correctly fixed. The procedure for this is provided with the customer letter. If any issues are detected by the customer, precautions should be taken in order to avoid the component falling and a Maquet representative should be contacted immediately in order to replace the broken ambient light module with a new one.

Device

H LED and PowerLED Ambient Light Modules (Surgical light)
  • Modèle / numéro de série
    H LED and PowerLED Ambient Light Modules (Surgical light)Model numbers: PWD700 and H LED 700 All lots manufactured from December 2006 to December 2012ARTG Number: 162037
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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