Events

Notificaciones De Seguridad De Campo acerca de Cios Alpha mobile C-Arm system

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 Healthcare GmbH.

¿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
    Slovenia
  • 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
    1) if the system language is set to english and the yyyymmdd date format 5 used, the patient‘s date of birth received through the dicom worklist and query/retrieve will be displayed with month and day reversed for patients who have birthdays on days 1 through 12. birth dates for days 13 through 31 are displayed correctly. the issue only appears to happen for days 1 through 12. 2) system crash may occur during dvd live recording if radiation is released when the dvd icon on the flc status bar is blinking. in this case error messages wili be displayed and a system reset is necessary. 3) sporadically the system will not be ready for radiation during reconnection of the trolley to the main unit. a system reboot is necessary.

Device

Cios Alpha mobile C-Arm system

Manufacturer

Siemens Healthcare GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS