Events

Rappel de Siemens Advia Centaur XPT System

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
    18834
  • Date de mise en oeuvre de l'événement
    2015-07-09
  • 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 a number of workflow issues with advia centaur xpt system software v1.0.1 and v1.0.2:, * the system does not display any indication of a missing required probe wash pack on the results screen., * the data shown on the "utilities->assay utilization" screen is incorrect for the totals of calibrators run on the instrument, * the data shown on the "utilities->assay utilization" screen and the printout report for assay utiliization may not match, the following issues are related to instruments connected to a lab automation system (las):, * if the instrument receives work orders while transition from the in-process state to the ready state, the sample will be routed to the instrument but may not be processed, *the system may stop processing samples from the las and hold a tube at the las sampling station.
  • Action
    Software to be upgraded

Device

Siemens Advia Centaur XPT System

Manufacturer

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