Events

Rappel de Siemens ADVIA Centaur and ADVIA Centaur XP, bulk fluid reserve assembly

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 Diagnostics Inc.

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
    17536
  • Date de mise en oeuvre de l'événement
    2014-10-17
  • 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
    Manufacturer has determined that on some systems a slight cracking of the tubing (the tubing for the wash1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.The cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. the potential for minimal fluid leakage outside the system exists. the drip will cause the reservoir to empty faster than the system expects.
  • Action
    Product to be modified

Device

Siemens ADVIA Centaur and ADVIA Centaur XP, bulk fluid reserve assembly

Manufacturer

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