Events

Alerta De Seguridad para C-Series Clinac® or Trilogy, versions 7.x and 8.x

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

¿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
    2011-11-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111124.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
    Field safety notice: varian c-series clinac® or trilogy, versions 7.X and 8.X medical device manufacturer, varian, has issued an urgent field safety notice concerning c-series clinac or trilogy accelerator, versions 7.X and 8.X. an event has been reported to varian 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. normal daily quality assurance testing and light field verification detected the discrepancy. varian has not received any report of misadministration as a result of the discrepancy. investigation found that a similar issue could arise on the gantry or couch axes. this does not affect the mlc. according to the local supplier, the affected device has been distributed in hong kong. varian has notified all possibly affected customers in hong kong and is continuing to evaluate possible technical solution for this issue. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

C-Series Clinac® or Trilogy, versions 7.x and 8.x
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian C-Series Clinac or Trilogy, versions 7.x and 8.x
  • Manufacturer
    Varian

Manufacturer

Varian