Events

Rappel de Siemens syngo RT Dosimetrist

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 AG.

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
    16745
  • Date de mise en oeuvre de l'événement
    2014-05-27
  • 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
    Under special workflow conditions involving reloading data, a newly created structure is renamed incorrectly by the software as the name of the last deleted structure. if this incorrect structure is used for treatment planning, there is a potential that an incorrect target is treated. this issue is only unlikely to be detected if the incorrect structure is very similar to the correct structure. the probability of a severe mistreatment is practically impossible with good clinical practice, as considerable changes from the original treatment plan would be detected during the treatment planning and approval.
  • Action
    Software to be upgraded

Device

Siemens syngo RT Dosimetrist
  • Modèle / numéro de série
    Model: , Affected: , Software version: Version 2.7
  • Manufacturer
    Siemens AG

Manufacturer

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