Events

Rappel de 4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Varian Medical Systems Australasia 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-2014-RN-00947-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-29
  • 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-00947-1
  • 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
    Varian received two reports from customers with c-series linear accelerators (linac) used with varian’s barcode conical collimator verification system (bccv) and brainlab’s exactrac patient positioning system where the user was able to clear the interlock for bccv, imposed by the 4ditc, from the exactrac console. in both reported cases, the user was employing a c-series he linac with 4ditc and both exactrac and bccv. the user was authorising the exactrac to the linac 4ditc. successive signals were sent from the exactrac to the 4ditc. the first signal cleared the exactrac interlock as intended. the exactrac console requested user confirmation of the second command to authorise. the user responded affirmatively. the signal was sent to the 4ditc, and the linac interlock associated with bccv was released. in such a situation, it may be possible to irradiate the patient using a cone other than what is specified by the treatment plan because the bccv verification was not completed.
  • Action
    Varian is reminding users of the correct procedures using auxiliary devices requiring the ADI interface and is providing recommended verification steps when carrying out treatment i.e., stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A permanent fix has been developed and a Varian representative will schedule the installation. This action has been closed-out on 12/08/2016.

Device

4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery ...
  • Modèle / numéro de série
    4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)Product code: H51Serial Numbers: H514278, H514544, H515102, H51B568, H513894, H515619 & H51B100ARTG Number: 116839
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Varian Medical Systems Australasia Pty Ltd

Manufacturer

Varian Medical Systems Australasia Pty Ltd