Events

Alerte De Sécurité sur BrainSCAN and iPlan RT treatment planning software versions

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
    2012-03-20
  • 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_20120320a.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
    Field safety notice: brainlab brainscan and iplan rt treatment planning software versions medical device manufacturer, brainlab ag, has issued a field safety notice concerning all brainlab brainscan and iplan rt treatment planning software versions. according to brainlab, the accuracy of the brainlab radiotherapy treatment planning software was not within clinically desirable limits for very small multi-leaf-collimator field sizes. if not recognized by the user with the recommended treatment plan quality assurance, the irradiation of such a treatment plan might lead to serious injury of the patient and/or ineffective treatment. brainlab is notifying affected customers with a field safety notice and will provide an updated instructions for use to them. the tentative availability of the update will be in june 2012. according to the local supplier, the affected devices were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

BrainSCAN and iPlan RT treatment planning software versions
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab BrainSCAN and iPlan RT treatment planning software versions
  • Manufacturer
    Brainlab AG

Manufacturer

Brainlab AG