Events

Rappel de Siemens syngo RT Therapist COHERENCE RTT Application 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
    20518
  • Date de mise en oeuvre de l'événement
    2016-08-17
  • 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
    New software update that addresses multiple issues including an issue communicated earlier:, 1. incorrect isocenter assignment when using multiple treatment plans with different isocenters based on one single planning ct and when a cbct has been acquired for each isocenter, 2.When auto field-sequencing (afs) is selected the pause is no longer present when treating a plan containing at least two beams with different isocentric table angles, 3. table movement due to different isocenters in imaging beams and treatment beams, 4. reference image has been associated to the wrong patient, 5.Incorrect calculated isocenter shift when using late resumption after interruption after beam 1 has been completed, 6.Multiple isocenter in session resumption f1 abort workflow is incorrect, 7. irrevocable assignment of the first reference 2d image, 8. after reverting plan changes in ois mosaiq changes performed on rt therapisttm become inactive.
  • Action
    Software to be upgraded

Device

Siemens syngo RT Therapist COHERENCE RTT Application Software
  • Modèle / numéro de série
    Model: , Affected: , Software version: 4.2.110 or 4.3.SP1 or 4.3.138 or 4.3.1_AR1 or 4.3.1_MR2 in combination with Oncology Information System ARIA (by VARIAN) or MOSAIQ (by ELEKTA Inc.)
  • Manufacturer
    Siemens AG

Manufacturer

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