Events

Rappel de ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094

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-00168-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-03
  • 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-00168-1
  • 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 have identified that incorrect values for the rotational collimator position may be displayed due to mechanical problems of the sensor slide. this can happen if the slide, on which the sensors used to detect the rotational collimator position are mounted, is not in its fully latched position. if the user is not aware of the incorrect values the patient can be mistreated by dose at the wrong location.Siemens were also made aware of a defective weld seam at overhead suspensions. due to such a defect the weld seam might break and the overhead suspension might fall down. this can lead to a severe injury of the patient or any other person.
  • Action
    Siemens is undertaking hardware updates regarding the collimator position detection and improper weld seam at overhead suspensions. To keep the sensor slide in its latched position, a locking plate will be mounted to the sensor slide. This will significantly reduce the risk that the sensor slide might be mechanically misaligned and cause incorrect values being displayed for the rotational collimator position. As reinforcement, a bracket will be added to the overhead suspension to ensure the stability of the connection. This will prevent the overhead suspension from falling down.

Device

ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094
  • Modèle / numéro de série
    ARTISTE, ONCOR and PRIMUS Digital Linear Accelerators Serial numbers equal to or higher than 3094ARTG Number: 165502
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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