Events

Alerte De Sécurité sur C-Series Clinac® or Trilogy, versions 7.x and 8.x

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
    2011-11-25
  • 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_20111124.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 c-series clinac® or trilogy, versions 7.X and 8.X medical device manufacturer, varian, has issued an urgent field safety notice concerning c-series clinac or trilogy accelerator, versions 7.X and 8.X. an event has been reported to varian involving a c-series clinac® accelerator. the event entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator. normal daily quality assurance testing and light field verification detected the discrepancy. varian has not received any report of misadministration as a result of the discrepancy. investigation found that a similar issue could arise on the gantry or couch axes. this does not affect the mlc. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers in hong kong and is continuing to evaluate possible technical solution for this issue. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

C-Series Clinac® or Trilogy, versions 7.x and 8.x
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian C-Series Clinac or Trilogy, versions 7.x and 8.x
  • Manufacturer
    Varian

Manufacturer

Varian