Events

Alerte De Sécurité sur Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2

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

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
    2013-07-05
  • Date de publication de l'événement
    2013-07-05
  • 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_20130705a.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: elekta digital accelerators with electrons and beam modulator mlci/mlci2 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning all digital accelerators with electrons and beam modulator, mlci/mlci2, agility or asymmetric heads, manufactured by elekta. according to the tga, the manufacturer has advised that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator. the manufacturer is asking users to check all affected machines against the default auto-tracking settings. a software update will be provided as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00667-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 july 2013.

Device

Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
  • Manufacturer
    Elekta

Manufacturer

Elekta
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DH