Events

Retiro De Equipo (Recall) de SYSMEX BLOOD COAGULATION ANALYZER CS-2000I

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
    76349
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-11-22
  • 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
    Under certain circumstances results could be assigned to a wrong sample. when the operator registers an order for micro mode and tries to modify the order by pushing the button in the order screen or the job list screen there is a risk of a mismatch between results and sample id numbers. the problem concerns qc as well as sample measurements which are measured in normal-mode. please note that this problem occurs even if no modification of the sample order has been done. pushing the button already triggers the error which is caused by a possible wrong feed forward of the sample rack.

Device

SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
  • Modelo / Serial
    Model Catalog: 10488584 (Lot serial: ALL); Model Catalog: CS-2100I (Lot serial: ALL); Model Catalog: 10488586 (Lot serial: ALL); Model Catalog: CS-2000I (Lot serial: ALL)
  • Descripción del producto
    SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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