Events

Rappel de MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)

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-2017-RN-01394-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-14
  • 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-2017-RN-01394-1
  • 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
    It has been concluded that there is a low failure rate that only can present itself on the devices of types and production identified in this letter. the issue relates to a crack in the metal of the spring arms that has the potential develop into a break. this potential for malfunction is caused by fissures near the weld seam at the front pivot of the spring arm. the design of the spring arm was improved in 2006. the devices are over ten years old and even so the vast majority have not failed. there have been related complaints, however to date no events involving injury have been reported.
  • Action
    Getinge is advising users that all potentially affected spring arms will be replaced with new spring arms.

Device

MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL ...
  • Modèle / numéro de série
    MAQUET HLX 2004-5 DF, HLX 3004-5 DF and XTEN DF cupolas Surgical Lighting System(used with ONDAL Acrobat 2000 Spring Arms manufactured between Jan 2004 - Dec 2006)Multiple part numbers affectedARTG 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