Events

Alerta De Seguridad O Notificaciones De Seguridad para Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Vital Images.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2013/023
  • Número del evento
    CON261810
  • Fecha
    2013-04-12
  • Fecha de publicación del evento
    2013-04-12
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON261810?tabName=allTabs
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Risk of measurement error when images are rotated at the time of reconstruction. there is the potential for volume errors of -50% and length errors of -29%, depending on the degree to which the images are rotated. this problem occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. for these scans, the images will shrink. the severity of the shrinking is dependent on the degree (or extent) of image rotation. the maximum error is seen with a 45 degree rotation which results in a length measurement being under-reported by 29% and a volume measurement being under-reported by 50%.
  • Acción
    Identify affected devices. Ensure members of staff are aware of the advice detailed in the manufacturer’s Field Safety Notice (FSN) and its update. Ensure that all measurements associated with the error described in the FSN are verified against results from other technologies. Notify Vital Images that you have received the FSN to arrange for installation of a software patch. Assess the need to review previous patients' treatment plans. Radiologists Radiographers Oncologists Medical physicists

Device

Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all ver...
  • Modelo / Serial
  • Descripción del producto
    Workstation software for computed tomography systems: Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX, all versions prior to version 6.3.3.
  • Manufacturer
    Vital Images

Manufacturer

Vital Images
  • Empresa matriz del fabricante (2017)
    Canon Inc
  • Source
    MHRA