Events

Alerta De Seguridad para 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1

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
    2011-08-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110819.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: 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1 medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1. 4d itc is designed to assist in providing radiation treatment for patients. there are circumstances in which the 4ditc may be involved in a failure to correctly record treatment history information. the majority of the issues experienced fall into one of three general categories: communication issues between the clinac sub-systems and the 4ditc. communication issues between the 4ditc and the oncology information system (ois). unplanned shut down of the 4ditc or the clinac during treatment. according to the manufacturer, the root cause is related to software design deficiency. varian has scheduled for a mandatory upgrade of the 4ditc to version 10.2 in order to address the above issues. varian also supplemented that the device has been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: [18 Aug 2011] 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems