Events

Rappel de Siemens RAPIDPoint 400/405/500 Systems and RAPIDLab 1200 Systemss

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
    20545
  • Date de mise en oeuvre de l'événement
    2016-08-19
  • 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, 55 Hugo Johnston Drive, Penrose, Auckland
  • Cause
    In an unlikely set of circumstances, there is a potential for the first and/or last name of one patient to be printed with patient id and result data from a different patient, even though those fields have been turned off on the system. the patient id and patient test result data, however, are correct on the analyser screen and the lis. only the printout may contain the incorrect first or last name data, which should not have been printed because those fields were turned off in setup.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens RAPIDPoint 400/405/500 Systems and RAPIDLab 1200 Systemss
  • Modèle / numéro de série
    Model: , Affected: RAPIDPoint® 400/405/500 Blood Gas Analyzer - RAPIDLab® 1240/1245/1260/1265 Blood Gas Analyzer
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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