Events

Rappel de Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Elekta 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-2013-RN-01290-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-03
  • 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-2013-RN-01290-1
  • 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
    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values. if the user does not do the quality assurance (qa) procedures after the calibration, it is possible that the user will not find the error made during the calibrationif the treatment table, gantry or collimator calibration is incorrect, and the user does not perform the recommended qa procedures, it can cause clinical mistreatment, with errors up to 6cm could go undetected and repeated over a number of fractions.
  • Action
    As an interim measure, Elekta is recommending users perform the daily QA procedures as per the Instructions for Use (IFU) and perform a daily check to ensure the magnitude and direction of the treatment table movements are correct. If a user has X-ray Volume Imager (XVI), Elekta is recommending users perform the QA procedures as per the XVI IFU and perform the daily phantom scan. All users of Integrity 3.1 software will be informed of a mandatory upgrade to software version 3.2 upon its release in February 2014. This action has been closed-out on 18/02/2016.

Device

Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)
  • Modèle / numéro de série
    Integrity, software version R1.1, 3.0, and R3.1 (Linear Accelerator)ARTG Number: 191025
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA