Events

Rappel de RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 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-2015-RN-00207-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-19
  • 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-2015-RN-00207-1
  • 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 issue concerns an error in dynamic multileaf collimator (dmlc) dose calculation for machines where the mlc is positioned above the jaws or the jaws are fixed. the output factor correction is computed from the irradiated area of the first control point but is applied to the entire beam. if the irradiated areas of the remaining control points are significantly different from the initial area, the output factor correction used for these control points will be incorrect.The maximum possible error in dose corresponds to the span of the output factor corrections of the beam model. for example, if the output factor corrections span 0.95-1.05, the maximum theoretical error is 10%, although for most plans, the error would be less.Machines that have backup jaw and the mlc below non-fixed jaws (e.G. varian linacs) and linacs that do not have backup jaw (e.G. siemens linacs and elekta agility) are not affected.
  • Action
    DMLC dose calculation for the affected linac types will be turned off in patch version 4.7.1 of RayStation, scheduled for market release April 2015. In the meantime, users are advised that if DMLC has been in use for affected linac types, review the beam models. The possible error in dose depends on the span of the output factor corrections. Deprecate any beam models that have been commissioned as DMLC capable for the affected linac types. Does not commission beam models as DMLC capable for the affected linac types.

Device

RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy t...
  • Modèle / numéro de série
    RaySearch RayStation 3.5, RayStation 4.0, RayStation 4.5, and RayStation 4.7 (Radiation therapy treatment planning system)Software versions affected: 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 and 4.7.0.15ARTG Number: 195288
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia