Events

Alerte De Sécurité sur iPlan RT Dose version 4.1

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Brainlab AG.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-06-22
  • Date de publication de l'événement
    2012-06-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120622b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: brainlab iplan rt dose version 4.1 medical device manufacturer, brainlab ag issued a medical device safety alert concerning radiation therapy treatment planning system iplan rt dose version 4.1 (v. 4.1.0, 4.1.1 and 4.1.2). according to brainlab, iplan rt dose 4.1 might position the isocenters and rt structures in the dicom ct image files incorrectly if all of the following conditions are met: two or more ct image sets have the same “frame of reference” (same coordinate system). the selected “reference set” and “alignment set” in iplan rt are different ct image sets, but have the same “frame of reference”. for the “reference set” and “alignment set” the used scanner settings differed at least in one of the following parameters: - pixel size - scan range (number of ct images and position) - slice thickness/distance or - matrix size the dicom “full export” - this is not the default “r& v export” - is used to export to a non-brainlab system (e.G. to another radiation therapy treatment planning system). brainlab explained that if all of the conditions above are met, the treatment dose might be delivered to a region different from the planned one. if the deviation would exceed clinically acceptable limits and at the same time be small enough to remain undetected, this could result in serious patient injury and/or ineffective treatment. according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

iPlan RT Dose version 4.1
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab iPlan RT Dose version 4.1
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG