Events

Alerta De Seguridad para Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators

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
    2011-09-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110915.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
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems