Events

Alerta De Seguridad para Clinac, Trilogy, Novalis Tx and Unique jaw carriers

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Varian Medical Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-08-20
  • Fecha de publicación del evento
    2012-08-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120820a.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian Clinac, Trilogy, Novalis Tx and Unique jaw carriers
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems