Events

Rappel de Siemens syngo RT Therapist software

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
    19482
  • Date de mise en oeuvre de l'événement
    2015-11-25
  • 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
    The issue occurs if one or more treatment plans with at least 2 isocenters based on one planning ct are used, and when a cone beam ct has been acquired for each isocenter., the system supports the workflow correctly until the user performs a manual change to another isocenter. at this point the visualization of the overlying images in adaptive targeting might be incorrect. if in this case the user performs a manual registration of the overlying images, this may result in an incorrectly calculated offset in adaptive targeting., applying this offset to the actual patient position can lead to delivering dose to the wrong location and therefore to patient mistreatment.
  • Action
    Software to be upgraded

Device

Siemens syngo RT Therapist software
  • Modèle / numéro de série
    Model: 8162815, Affected: , Software version: 4.3.138, 4.3.SP1, 4.3.1_AR1, 4.3.1_MR2
  • Manufacturer
    Siemens AG

Manufacturer

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