Events

Rappel de Biograph Horizon with VJ20A Software

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-2018-RN-00126-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-08
  • 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-2018-RN-00126-1
  • 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 healthineers has become aware of an issue with the pet quality control software that introduces an error into the pet normalization file. as a result there may be minimal visual and quantitative impacts to the pet images acquired and reconstructed with petsyngo vj20a software.
  • Action
    Siemens will be in contact with affected customers to arrange for a software update to be installed. In the event that users have any concerns about data that has been previously acquired and reconstructed prior to correction, users may refer to the Customer Letter for instructions for reconstructing data with a new normalization file.

Device

Biograph Horizon with VJ20A Software
  • Modèle / numéro de série
    Biograph Horizon with VJ20A SoftwareCatalogue Number: 10532746 and 10532748ARTG Number: 271560 (Siemens Healthcare Pty Ltd - Combination diagnostic imaging system, PET/CT)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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