Events

Rappel de ADVIA Centaur XPT System with software versions V1.0 to V1.2. 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-2017-RN-00208-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-08
  • 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-00208-1
  • 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
    Multiple software issues have been identified for software versions v1.0 to v1.2. these issues may affect the operation and workflow of the advia centaur xpt system, and the potential exists for an apparent delay to testing. the issues are detailed in the customer letter and relate to the following: system status unknown, las communication, qc profiles, 'no primary' error, and lis specification.
  • Action
    The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.

Device

ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical devi...
  • Modèle / numéro de série
    ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).Siemens Material Number: 10711433Software 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, 11219656)V1.1 (Bundle 1.1.243 SMN 11221979, 11222064)V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813)ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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