Events

Rappel de Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems

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-00120-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • 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-00120-1
  • 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
    The manufacturer, getinge, has received complaints concerning unintentional drifting of the cupola during surgery due to prematurely worn out brake screws. the observed movement is a slow rotation of the cupola around the axis, potentially shifting the light patch away from the wound.Clinical evaluations concluded that there is a low risk of injury or other health consequences expected for the patient or the user. only one (i.E. the heavier) cupola of a configuration is concerned by the malfunction, and the second cupola provides sufficient illumination of the surgical area if the issue occurs during surgery.
  • Action
    Getinge is advising users that a service technician will be correcting all affected units.

Device

Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting Systems
  • Modèle / numéro de série
    Maquet PowerLED, HLED 700 SF and Volista 600SF Surgical Lighting SystemsManufactured between August 2009 and July 2014Multiple Part Numbers affected ARTG 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