Notificaciones De Seguridad De Campo acerca de Biograph TruePoint systems running PETsyngo 6.7.x software

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Siemens Medical Solutions USA, Inc. .

¿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
    Field Safety Notice
  • País del evento
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Depending on the type of uniform phantom utilized to perform the pet quality control, the pet calibration factor may be biased due to the system using a specific mu-value of 0.1 cm-1 which is based on the siemens solid germanium-68 phantom. the system will use this default mu-value, regardless of the actual mu-value of the phantom utilized for pet quality control; this may cause a variation in the quantification of the attenuation corrected pet images in order to correct for the variation in mu-values, we recommend that you perform the scanner cross calibration procedure after the 6.7.X software upgrade as well as every time the pet quality phantom is replaced. in addition to cross calibrating the pet scanner to the dose calibrator, this procedure will also account for the mu-value of a liquid or third-party solid germanium-68 quality phantom to ensure more accurate quantification in the pet attenuation corrected images. for complete instructions on the cross calibration procedure, please see your siemens biograph operator’s manual. .

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    AMPMDRS