Events

Rappel de iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab Australia 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-01293-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-11
  • 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-01293-1
  • 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
    Incorrect patient positioning at the linac might occur, if all of the following conditions are met:1. at least two different ct datasets are being used and have been both localized and fused toeach other in the same treatment plan.2. the latest ct scan used with the localizer is not assigned as both reference set and alignmentset (for definitions, see the appendix).3. patients are positioned at the linac using one of the following positioning solutions:- target positioner- exactrac v.4.5 or v.5.X- exactrac vero (from v.2.1 up to v.3.2.1)the magnitude of potentially incorrect patient positioning is given by the difference in patient position inside the localizer during the two ct scans, one of which was assigned to the reference set and the other to the alignment set.
  • Action
    1) Brainlab will provide existing potentially affected iPlan RT / iPlan RT Dose customers with this product notification information. 2) Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. 3) Brainlab will refine the instructions for use of the iPlan RT treatment planning software in regard to implications of Alignment Set and Reference Set selections and will provide this user guide update to existing affected customers together with the software update. This action has been closed-out on 22/08/2016.

Device

iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localis...
  • Modèle / numéro de série
    iPlan RT / iPlan RT Dose Radiation Treatment Planning Software used in combination with a localiser and one of the positioning solutions Target Positioner, ExacTrac v.4.5 or v.5.x, ExacTrac Vero (versions 2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)ARTG Number: 121114
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd