Events

Alerte De Sécurité sur C-Series Clinac, version 2.x through 6.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
    2014-04-14
  • Date de publication de l'événement
    2014-04-14
  • 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_20140414.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: varian c-series clinac, version 2.X through 6.X medical device manufacturer, varian, has issued a medical device safety alert concerning c-series clinac accelerators equipped with software versions 2.X through 6.X. the affected models are 600c, 600cd, 6ex, dbx, 2100c, 2100cd, 2300cd, 21ex, 23ex, dmx and dhx. according to the manufacturer, an event has been reported 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. the manufacturer advises users to take adequate precautions and exercise due care in aspects of position readout accuracy with c-series clinac accelerators equipped with the affected software versions. this does not affect the multileaf collimator (mlc). according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 april 2014.

Device

C-Series Clinac, version 2.x through 6.x
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian C-Series Clinac, version 2.x through 6.x
  • Manufacturer
    Varian

Manufacturer

Varian