Events

Retiro De Equipo (Recall) de ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER

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
    28981
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-02
  • 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 healthcare diagnostics is conducting a field corrective action for advia 120 hematology systems. the advia 120 optics cover or hood is located on the very top of the advia 120 analyzer. when the optics cover is raised it is supported by two gas struts which are attached to the cover on the left and right sides. over time it is possible that these struts may lose their effectiveness and fail to support the optics cover in the open position. this could cause the cover to fall during maintenance procedures.

Device

ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER
  • Modelo / Serial
    Model Catalog: 10360959 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 10360958 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    ADVIA 120 HEMATOLOGY SYSTEM - ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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