Events

Alerte De Sécurité sur BrainSCAN version 5.31 and 5.32

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.

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
    2011-11-15
  • 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_20111116.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 version 5.31 and 5.32 medical device manufacturer, brainlab, has issued a field safety notice advising users of a potential undesirable effect that might occur with the pencil beam dose algorithm of brainscan version 5.31 or version 5.32 under specific conditions. the brainscan pencil beam dose algorithm may overestimate the dose delivered to the target region if both of the following conditions are met: the scatter measurements have been performed according to the technical reference guide (trg) “brainlab physics” (any revision), i.E. the scatter table was measured and implemented without values for equal jaw and mlc field sizes. and in the treatment plan, the margin between jaw position and mlc field shape is set to a value smaller than the default margin of 8mm in leaf movement direction and 2mm in direction perpendicular to leaf movement. as a consequence, a dose lower than planned and intended might be delivered to the patient, potentially resulting in ineffective treatment. according to the local supplier, the affected device has been distributed in hong kong. if you are in possession of the affected products, please contact supplier for necessary actions.

Device

BrainSCAN version 5.31 and 5.32
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab BrainSCAN version 5.31 and 5.32
  • Manufacturer
    Brainlab

Manufacturer

Brainlab