Events

Alerta De Seguridad para XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1

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
    2014-07-22
  • Fecha de publicación del evento
    2014-07-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140722.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 xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning xvi r4.0 to r4.2.1, r4.5.0, r4.5.1 and r5.0.0 to r5.0.1, manufactured by elekta. the user does an online volumeview acquisition and registration. the user accepts the registration and the “table move assistant” dialog box appears. two different scenarios mentioned in the fsn can result from the same error. this issue may cause clinical mistreatment and collision risk resulting in fatal injury to the patient. the manufacturer advises users of the followings: monitor the “relative actual” and “absolute actual” columns of the “table move assistant” dialog box, if these values are blank do not press the table asu buttons on the function keypad (fkp); or if users see a movement larger than the “relative actual” and the “absolute actual” does not update, they should follow the procedure mentioned in the fsn to correct the error. when doing volumeview acquisitions with an external bld attached, users should make sure that the stop angle of the volumeview parameters is in the lower half of the gantry rotation. this decreases the risk of a collision with the patient. a later software release of xvi will be supplied which gives a solution to this problem. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con433868 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 jul 2014.

Device

XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Elekta XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1
  • Manufacturer
    Elekta

Manufacturer

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