Events

Alerte De Sécurité sur Clinac, Trilogy, Novalis Tx and Unique jaw carriers

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
    2012-08-20
  • Date de publication de l'événement
    2012-08-20
  • 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_20120820a.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 clinac, trilogy, novalis tx and unique jaw carriers medical device manufacturer, varian medical systems, has issued a field safety notice concerning clinac, trilogy, novalis tx and unique jaw carriers. according to varian, an anomaly has been identified with the clinac, trilogy, novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack. if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an underdose of the intended target volume. this condition was found on some machines. no patient mistreatments were reported to varian medical systems. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 august 2012.

Device

Clinac, Trilogy, Novalis Tx and Unique jaw carriers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Varian Clinac, Trilogy, Novalis Tx and Unique jaw carriers
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems