Events

Rappel de 550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)

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-00455-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • 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-00455-1
  • 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
    The following safety issues have been identified with the 550 txt treatment table :1. in very rare instances, the actual table position may significantly deviate from the position at the table side control and the linac control console, but no interlock occurs.2. in sporadic cases the following issue for the table axis lateral, longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.
  • Action
    Siemens has developed a new version of the 550 TxT Treatment Table software. In addition to the software update, Siemens is providing 550 TxT Treatment Table Addendum for the IFU that describes new table error codes. The software update will prevent the failure mode by the following actions: 1. A plausibility check was introduced for comparing the two independent encoder systems of each table axis. 2. The time between two encoder comparisons was reduced to 50ms and an error code was introduced.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)
  • Modèle / numéro de série
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators (LINAC)Lot Number: 7346534ARTG Number: 165502
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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