Events

Alerte De Sécurité sur Elekta XVI 4.5 and 4.6

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 Ltd.

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
    2011-10-19
  • 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_20111019.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: elekta xvi 4.5 and 4.6 medical device supplier, elekta ltd, issued an important notice to bring users attention to certain precautionary measures required for the operation of elekta xvi. xvi dual registration can inform customers if an organ at risk has moved in relation to the target since the planning stage of treatment. it was discovered at customer site that there is a software error leading to compromise of the dual registration, and this issue applies to release 4.5 and 4.6. an important notice a357 was sent out to all xvi 4.5 and 4.6 users. the notice informs customers using dual registration with compromise how to recognize the issue and avoid it. a later software release of xvi will give a solution to this problem. according to the local supplier, the affected products have been distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Elekta XVI 4.5 and 4.6
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Elekta XVI 4.5 and 4.6
  • Manufacturer
    Elekta Ltd

Manufacturer

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