Events

Alerta De Seguridad para C-Series Clinac, version 2.x through 6.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
    2014-04-14
  • Fecha de publicación del evento
    2014-04-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140414.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 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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Varian C-Series Clinac, version 2.x through 6.x
  • Manufacturer
    Varian

Manufacturer

Varian