Events

Rappel de ADVIA Centaur XPT System

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-00720-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-30
  • 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-00720-1
  • 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 healthcare diagnostics has identified issues with all the advia centaur xpt system software versions that may affect the results generated by the system as described below:1. there is potential for discrepant qc and patient results. stop running the system until it is serviced if the conditions occur. the probability of this failure occurring is extremely unlikely.2. if the daily cleaning procedure (dcp) fails to complete there is potential for discrepant qc and patient results. the probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting the dcp.3. there is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. no erroneous results will be reported.Siemens advises the overall risk to health is low.
  • Action
    Siemens is asking users to follow the detailed instructions in the customer letter.

Device

ADVIA Centaur XPT System
  • Modèle / numéro de série
    ADVIA Centaur XPT SystemSiemens Material Number: 10711433All the ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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