Events

Rappel de Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option

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 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-2014-RN-00614-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-05
  • 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-2014-RN-00614-1
  • 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 became aware of an incident where a patient was pinched between the moving gantry and the tabletop during an auto-sequenced treatment. in this case, an automatic gantry movement during an auto-sequenced treatment led to the collision because: - the auto-sequenced treatment has been created including beams with table angles. and - no dry run has been performed. and - the therapist did not monitor the patient during treatment delivery.
  • Action
    Siemens is providing preventative work around instructions in its letter to customers, relating to beam placement, utilisation of dry runs after each change to the treatment plan, treatment interruption during patient repositioning, user care in field entries, patient monitoring and use of an optional inbuilt collision avoidance system such as ‘OPTIGARD’ if available. Additionally, therapist-identified potential collision between the gantry and the patient during use is preventable by the therapist by three separate button mechanisms. Siemens is also investigating a new method of determining whether there is a significant probability of collision between the LINAC gantry and the patient or the table.

Device

Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment ...
  • Modèle / numéro de série
    Digital Linear Accelerators of type ARTISTE, ONCOR and PRIMUS with Automatic Sequenced Treatment Delivery Option Catalogue/Lot number: LINAC Systems (Material Numbers 4505200, 5857912, 7360717, 8139789) with SIMTECARTG Number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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