Events

Rappel de Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302

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-2017-RN-00284-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-28
  • 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-2017-RN-00284-1
  • 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 has identified a risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table using the simtec auto field sequence option. the following issues will be addressed in the software update solution "auto field sequence (afs) motion protection”:- risk of collision due to automatic gantry movements in case of lateral table shifts and- unwanted automatic gantry movements in case of table configuration set to “manually” and the movement order to be “table first”.
  • Action
    Siemens is advising affected users to be aware of the updated software solution “Auto Field Sequence (AFS) Motion Protection” which will be implemented at the Control Console of their Digital Linear Accelerator. This software will not execute a movement if a potential collision is anticipated and that users may, in such cases, perform the planned movement manually. Users are further advised that despite these safety measures, there might be scenarios which are not covered by the software. Therefore, during an auto-sequence delivery, users must be aware, at all times, of any movement of the gantry, the treatment table and the applied table offsets or overrides according to the treatment plan.

Device

Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13...
  • Modèle / numéro de série
    Artiste, Oncor and Primus Digital Linear Accelerators running Control Console software version 13.0.302ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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