Events

Rappel de ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

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-00181-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-20
  • 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-00181-1
  • 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
    When the instrument cover is raised, the cover is supported by a gas spring attached at the middle of the cover. over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. this may lead to the cover falling unexpectedly.
  • Action
    Siemens is requesting their customers to ensure that any objects placed on the cover are removed prior to opening. If the cover is unable to stay partially raised customers are requested to contact Siemens Technical Support to arrange for the gas spring to be serviced. Siemens technical support representatives will be routinely inspecting the gas spring on regular preventive maintenance cycles or service visits.

Device

ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))Siemens Material Number: 10338631ARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA