Events

Rappel de syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare Pty Ltd.

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
    RC-2016-RN-01087-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-18
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01087-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Siemens are advising users regarding a bundled update of the syngo rt oncologist software. the update addresses the following issues:- incorrect offset calculation in adaptive targeting option. in rare cases, an identical region of interest (roi) label for the planning isocenter and the treatment isocenter may have been randomly generated during image processing. in this case the offset calculation in adaptive targeting during image review has been incorrect. - problems with structure name in case of using structure operation functionality in segmentation. in special scenarios within the structure operation functionality of the segmentation tab, the system did not store the selected name from the list of predefined names when creating a new structure. after reloading the data, the system replaced the name of this structure by the name of the former last deleted structure.There have been no reports of injuries as a result of the reported issues.
  • Action
    Siemens is advising users of the potential issues in order for users to maintain awareness until the software correction is implemented as a permanent correction. This action has been closed out on 16 June 2017.

Device

syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a c...
  • Modèle / numéro de série
    syngo RT Oncologist with software version 4.2.X or 4.3.X (image processing device that can be a component of one or more radiation therapy systems)ARTG Number: 181846
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA