Events

Rappel de Siemens Immulite 2000 and Immulite 2000 XPi, Reagent Carousel Temperature Sensor

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
    18449
  • Date de mise en oeuvre de l'événement
    2015-04-29
  • 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
    Siemens has identified that affected systems have been manufactured with a defective reagent carousel temperature sensor pcb or may have had a part replacement with a defective pcb assembly., a particular set of the temperature sensor boards were built incorrectly. the incorrectly assembled temperature sensor boards may cause icing on the reagent carousel casting. if there is icing within the reagent carousel, there is a potential for the reagent carousel to encounter a mechanical jam which will stop the system from processing samples and will generate errors.
  • Action
    Product to be modified

Device

Siemens Immulite 2000 and Immulite 2000 XPi, Reagent Carousel Temperature Sensor

Manufacturer

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