Events

Retiro De Equipo (Recall) de XN-L SERIES

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

¿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
    135240
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-11-30
  • 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
    After the change to standard time from daylight savings time the analyzer's time may not be consistent with local time. the analyzer date may also not reflect the current date. the discrepancy is due to a time difference between the windows operating system and the xn-l program time. after changing the time and date in the analyzer's software and cycling power to the analyzer the date and time may not be correct when the analyzer restarts. patient and quality control (qc) results are not impacted. however the analysis date and time displayed printed and transmitted with the results may not reflect the actual date and time the sample was run.

Device

XN-L SERIES
  • Modelo / Serial
    Model Catalog: XN-450 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: XN-550 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    SYSMEX XN-L SERIES
  • Manufacturer
    SYSMEX CORPORATION

Manufacturer

SYSMEX CORPORATION
  • Dirección del fabricante
    KOBE
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    HC