Events

Alerte De Sécurité sur TrueBeam and TrueBeam STx

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

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
    2011-11-08
  • 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_20111108.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: varian truebeam and truebeam stx medical device manufacturer, varian, has issued an urgent medical device correction concerning truebeam and truebeam stx. it has been identified with the truebeam and truebeam stx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. the presence of this elongated beam spot shape can be detected by a larger than expected difference in the penumbra between the radial and transverse planes, as measured by beam profile scans. varian is notifying all possibly affected customers with the notice and developing a correction for this issue. 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

TrueBeam and TrueBeam STx
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian TrueBeam and TrueBeam STx
  • Manufacturer
    Varian

Manufacturer

Varian