Events

Rappel de Artis Q, Q.zen, zeego, zee systems

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens Healthcare GmbH.

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
    21959
  • Date de mise en oeuvre de l'événement
    2017-09-12
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    In the application "dsa roadmap" the artis system's intended behavior is to reject the stored vesselmap from previously acquired dsa if the patient table was moved during the roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses it for the further roadmap workflow steps. depending on the amount of table movement which was applied during the roadmap workflow, the dsa vesselmap might be overlaid as vessel tree at a position which does not fulfill the requirements for accuracy.
  • Action
    Software to be upgraded

Device

Artis Q, Q.zen, zeego, zee systems
  • Modèle / numéro de série
    Model: , Affected: Lot number – 10094137, 10848281, 10848282, 10848280, 10848283, 10094135, 10094139, 10848355, 10280959, 10848353
  • Manufacturer
    Siemens Healthcare GmbH

Manufacturer

Siemens Healthcare GmbH
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA