Events

Alerta De Seguridad para Somatom Definition FORCE with VA50A, VA50A_SP2

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

¿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
    2016-04-06
  • Fecha de publicación del evento
    2016-04-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160406a.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: somatom definition force with va50a, va50a_sp2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning somatom definition force with va50a, va50a_sp2, manufactured by siemens. [material number: 10742326]. the manufacturer recently detected that the use of the neonate head with pediatric kernel hp38, a special image reconstruction programme for ct images, could result in artefacts and furthermore in misdiagnosis, as any or delayed medical treatment within the skull is a surgical and time critical event. according to the manufacturer, this arithmetic error within neonate head with pediatric kernel hp38 is not affecting any other kernels and reconstruction modes. as the reconstruction of images uses the raw data in any case, no additional dose or scan with additional dose has to be applied to the patient. in any case of uncertainty, users are advised to use additional and alternative diagnostic systems before they start the medical treatment. the manufacturer is advising users not to use neonate head with pediatric kernel hp38 anymore until they are informed about the corrective actions to improve this behaviour. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-28-march-to-01-april if you are in possession of the affected products, please contact your supplier for necessary actions posted on 6 april 2016.

Device

Somatom Definition FORCE with VA50A, VA50A_SP2
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: SOMATOM Definition FORCE with VA50A, VA50A_SP2
  • Manufacturer
    Siemens.

Manufacturer

Siemens.