Events

Rappel de ADVIA Centaur XPT 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 Healthcare 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-2016-RN-00837-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-24
  • 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-2016-RN-00837-1
  • 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
    Siemens has determined that certain waste reservoirs in advia centaur xpt system were manufactured with walls that are below the nominal specification, potentially causing the following problem when the reservoir is under vacuum: - the seam at the bottom of certain reservoirs could crack slightly and have a slight leak.- the fitting at the bottom of the reservoir could exhibit some leaks at the interface between the reservoir and the fitting.If a leak occurs due to a crack in the bottom of the reservoir, foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with vacuum low error # 01 600 13 24.
  • Action
    Siemens are advising users to avoid any potential leak onto the floor by performing the following action during the weekly maintenance: - Verify that no fluid has accumulated under the Waste reservoir. - Verify that the glass jar in the bulk fluid drawer is empty and is not foaming. Siemens will replace the defective reservoir.

Device

ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)Siemens Material Number: 10711433ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA