Events

Retiro De Equipo (Recall) de ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION

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

¿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
    78789
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-09-11
  • 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
    1)doppler signals may be truncated and peak gradients to be potentially obscured may result in the underestimation of peak velocity and a disease process 2)user records of heart be recorded using calipers on the ecg the heart rate value does not get reset during a new patient registration and calculations are based on the previous patient's results. 3)when a user searches for data the search result is for the patient in the study browser new study results are saved under patient the study brower is focused on. 4)when new patient is registered with no new parameters image from the last patient is appearing in the text for the new patient could result in misdiagnosis.

Device

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT PREMIUM EDITION

Manufacturer

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