Events

Retiro De Equipo (Recall) de CIOS ALPHA

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    34525
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens is notifying customers of the following potential software issues with the cios alpha: 1) if the system language is set to english and the yyyymmdd date format is 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 while the dvd icon on the flc status bar is blinking. in this case error messages will 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
  • Modelo / Serial
    Model Catalog: 10308191 (Lot serial: 11138); Model Catalog: 10308191 (Lot serial: 11137)
  • Descripción del producto
    CIOS ALPHA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC