Retiro De Equipo (Recall) de XN-11 MODULE

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

¿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
    109839
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-11-18
  • País del evento
  • 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
    Sysmex america inc. (sai) has become aware through customer complaints that the computer power supply on the information processing unit (ipu) used with the sysmex xn-series xt-series and xs-series hematology analyzers shut down disabling the analyzer. the power supply has an over-voltage regulator to halt power in the presence of a power spike and prevent potential damage to the power supply and the associated device. the regulator in the power supplies within a specific serial number range were found to be more sensitive than necessary to normal power fluctuations causing the shutdown of the ipu during normal operation.

Device

  • Modelo / Serial
    Model Catalog: XN-11 (Lot serial: > 10 Lots contact MFG); Model Catalog: XS-1000I (Lot serial: > 10 lots contact MFG); Model Catalog: XT-2000I (Lot serial: > 10 lots contact MFG); Model Catalog: XN-10 (Lot serial: > 10 lots contact MFG)
  • Descripción del producto
    XN-11 Module;XS-1000i Hematology Analyzer;XT-2000i Hematology Analyzer;XN-10 Module
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
  • Source
    HC