Events

Rappel de Monaco and Focal (radiation treatment planning systems)

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-2014-RN-00896-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-14
  • 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-00896-1
  • 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
    When dicom exporting an arc plan (vmat, dynamic conformal or 3d static arcs) and using the composite field sequencing (cfs) feature, the dicom exported plan will not match the approved treatment plan.The problem occurs when the starting gantry angle of the second arc is exactly 180 degrees and the stop angle of first beam is greater than 180 degrees away from the start position of the second arc. cfs is designed to combine arcs into a single beam to streamline delivery. however, under these specific circumstances, the start and stop points for the arcs become corrupted.Sites affected will be those:1. running monaco release 3.20 and higher, and 2. with elekta or siemens linacs, and3. with any of the following licenses: vmat or dynamic conformal or 3d (static arcs), and4. using cfs when dicom exporting plans.Customers with focal releases 4.70 and 4.80 are also affected by this issue when focal is used with monaco and meet the criteria above.
  • Action
    Elekta is advising that to avoid the problem, do not use 180 degrees for the starting gantry angle of the second arc. Using 180.1 or 179.9 degrees as the starting gantry angle will completely avoid this issue. The problem will be resolved in updates to Monaco and Focal software i.e., Monaco 3.30, Monaco 5.00, and Focal 4.80. The expected release date is September 30, 2014. This action has been closed-out on 04/08/2016.

Device

Monaco and Focal (radiation treatment planning systems)
  • Modèle / numéro de série
    Monaco and Focal (radiation treatment planning systems)Monaco: versions 3.20.00 and higher Focal: versions 4.70 & 4.80 ARTG numbers: 215960 & 186853
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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