Events

Alerta De Seguridad para MLCi and MLCi2 radiation heads

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

¿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
    2012-04-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120423a.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: elekta mlci and mlci2 radiation heads medical device manufacturer, elekta limited, has issued a field safety notice concerning all mlci and mlci2 radiation heads. according to elekta, it is possible that the backup diaphragms drive mechanism can become loose after many years in clinical operation. this can cause a backlash between the positioning mechanism and the diaphragm. this backlash can be seen by the usual x-ray and field calibration checks when the field is moved from a small to a large field size. if there is a problem it will be that the backup diaphragm is not in the correct position behind the mlc leaf tips. if the affected customers do not do the recommended planned maintenance program, screws can become lost from the positioning mechanism. as the problem can lead to clinical mistreatment if it is not repaired, customers are advised to conduct a weekly recommended physics check of the x-ray and light field size calibration to make sure the field is moved from a small to a large field size. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

MLCi and MLCi2 radiation heads
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta MLCi and MLCi2 radiation heads
  • Manufacturer
    Elekta Limited

Manufacturer

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