Events

Rappel de Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly

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.

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-2015-RN-00550-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-22
  • 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-2015-RN-00550-1
  • 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
    Due to a production fault in a specific production lot of the triple-focus x-ray tube assembly, there is a possibility that the "small focus" may fail. if this occurs, no further radiation release will be possible from this focus source. the "large focus" and "micro focus" will still be operational.
  • Action
    This action is a follow-up to RC-2014-RN-01035-1. Following from the software updated implemented under the original action Siemens are now replacing all potentially affected X-ray tube assemblies with a version in which the cause of the potential malfunction has been eliminated. This action has been closed-out on 11/08/2016.

Device

Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assembly
  • Modèle / numéro de série
    Artis zee and Artis zeego systems used in conjunction with a triple focus x-ray tube assemblyCatalogue/Lot numbers: X-ray tube assemblies 10144184 and 10145086 from a specific production lotARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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