Events

Alerta De Seguridad para Apex Collimator

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
    2013-02-05
  • Fecha de publicación del evento
    2013-02-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205a.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 apex collimator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning apex collimator manufactured by elekta limited. according to the manufacturer, if the apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates. the inhibit may or may not show in the tcs restrictions list in the view restrictions dialog box, but it still prevents the machine movements. if the touchguard button is used to override the inhibit and rotate the gantry, the apex collimator may disconnect from the radiation head and cause serious injury and damage to the equipment. elekta recommends the users to follow the advice as mentioned in the field safety notice to solve the problem. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con226996 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 february 2013.

Device

Apex Collimator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta Apex Collimator
  • Manufacturer
    Elekta Limited

Manufacturer

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