Events

Alerta De Seguridad para SL75/5 Linear Accelerator

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

¿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
    2012-08-29
  • Fecha de publicación del evento
    2012-08-29
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120829.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: elekta sl75/5 linear accelerator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all sl75/5 linear accelerator, manufactured by elekta. according to the manufacturer, there was malfunction of the semikron diode of sl75/5. this diode is fitted as charging diode d8 but can also be fitted as reverse diode d7 on later machines. they can be found on the modulator chassis assembly. if a malfunction of the semikron diode occurs, the ceramic body of the diode can rupture. this can cause ceramic material and silicone oils to eject from the modulator assembly which may cause injury to on-site service personnel. there are currently no reported incidents of this kind on sl75/5 machines. furthermore, the manufacturer recommends that: service personnel should always wear protective safety glasses, when they do work on the modulator assembly with the covers removed. users should make sure the door of the modulator chassis assembly is closed when the digital accelerator is in operation. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 august 2012.

Device

SL75/5 Linear Accelerator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta SL75/5 Linear Accelerator
  • Manufacturer
    Elekta

Manufacturer

Elekta
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    DH