Events

Alerte De Sécurité sur Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators

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 Medical Systems.

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
    2011-09-15
  • 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_20110915.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
    Urgent field safety notice: clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators, due to the potential for gantry collisions during remote motion, which may result in patient injury. varian is sending a notification letter to remind users of varian products to take adequate precautions and exercise due care in all aspects of gantry motions, particularly remote motions. failure to follow the instructions in varian’s user documentation, warnings and other product labeling may increase the risk of a collision between the accelerator gantry and the patient, couch, or nearby equipment or personnel. according to the supplier, the affected devices have been distributed hk. if you are in possession of the affected product, please contact your supplier in case of doubt.

Device

Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems