Events

Retiro De Equipo (Recall) de SOMATOM DEFINITION - MAIN UNIT

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
    25800
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-12-10
  • 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
    Somatom definition ct systems running software version syngo ct 2012b (va44) may experience a malfunction which may lead to a system display freeze during interventional procedures. when the function "auto save last displayed images as key images" is activated during an interventional procedure the software configuration allows conflicting access to the ct system image database which may cause a system display freeze to occur. when this happens normal interaction with the system is no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognize the malfunction and continue the interventional procedure. in view of the misleading information shown on the display an injury of the patient cannot be fully ruled out.

Device

SOMATOM DEFINITION - MAIN UNIT
  • Modelo / Serial
    Model Catalog: 77 40 769 (Lot serial: ALL); Model Catalog: 8098027 (Lot serial: ALL); Model Catalog: 10590000 (Lot serial: ALL); Model Catalog: 10430603 (Lot serial: ALL)
  • Clasificación del producto
    Radiology Devices
  • Descripción del producto
    SOMATOM DEFINITION -MAIN UNIT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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