Events

Rappel de RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-2016-RN-00182-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-16
  • 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-2016-RN-00182-1
  • 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
    A software bug has been reported that when using certain roi (region of interest) editing tools, if simultaneously right clicking, pressing ctrl-s or ctrl-z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. in order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the roi. saving of an unintended state may lead to ineffective and/or unintended radiation therapy. the patient views and the beam’s eye view will always be displayed correctly in the plan approval dialog and in the plan reports. closing and reloading a case will always generate correct views. dose is always computed based on the stored system state.
  • Action
    This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to: -Always release the left mouse button before using other keys or mouse buttons. -If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017.

Device

RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)
  • Modèle / numéro de série
    RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)Software build number : 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia