Events

Alerte De Sécurité sur Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0

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
    2015-12-01
  • Date de publication de l'événement
    2015-12-01
  • 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_20151201.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 brain metastases v1.0.0 and adaptive hybrid surgery analysis v1.0.0 the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning the brainlab brain metastases v1.0.0 and adaptive hybrid surgery analysis v1.0.0 manufactured by brainlab. under very specific circumstances, there is the potential for large objects with fine resolution to be displayed cropped when imported from smartbrush into brainlab brain metastases v1.0.0 or adaptive hybrid surgery analysis v1.0.0. for the brain metastases v1.0.0, if the cropped object is not recognised by the user before the plan is used for treatment and the deviation exceeds clinically acceptable limits, this could result in ineffective radiation treatment, serious patient injury, or even death of the patient. structures that are cropped in brain metastases are also cropped in the exported dicom rt structure set files. for the adaptive hybrid surgery analysis v1.0.0, if determination regarding the potential for radiotherapy is made, the incorrect information displayed can have an effect on clinical decisions. if the determination is done during surgery this could even, in a worst case scenario, mislead the user in regards to assessing the extent of resection during this surgery. the manufacturer will provide a software update with this issue solved. in the interim, users are advised to implement the workarounds instruction provided by the manufacturer. for details, please refer to the tga website:http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-01164-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 december 2015.

Device

Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0
  • Manufacturer
    Brainlab

Manufacturer

Brainlab