Events

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

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-00157-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-12
  • 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-00157-1
  • 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
    It has come to siemens attention that it is possible for patients or operators to have their fingers trapped and pinched between the table top and the bottom frame of the 550 txt treatment table.Secondly the manufacturer has received a report on an incident in which a cable inside the 550 txt treatment table has been damaged due to contacting a moving part. this resulted in a short circuit which overheated an electronic circuit board inside the table base.
  • Action
    Siemens is advising users that the affected treatment tables will be modified to increase the gap between the table top and the base frame to more than 25mm to prevent fingers being trapped or pinched. Siemens will also be modifying the cable routing inside the patient table base in order to ensure the affected cable cannot contact moving parts.

Device

550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear Accelerators
  • Modèle / numéro de série
    550 TxT Treatment Table used with PRIMUS, ONCOR and ARTISTE Digital Linear AcceleratorsCatalogue number: 7346534ARTG number: 165502
  • Manufacturer
    Siemens Ltd

Manufacturer

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