Events

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
    22233
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-04
  • 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
    The protective plastic sheet that is intended to cover and protect electronic components inside the xn-series analyzers was not positioned correctly during manufacturing. reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. the salt build-up created a salt bridge that allowed current to continue to flow create heat and eventually ignite adjacent resin parts inside the analyzer.

Device

XN-11 MODULE
  • Modelo / Serial
    Model Catalog: XN-11 (Lot serial: A1001-A1124); Model Catalog: XN-11 (Lot serial: A1171); Model Catalog: XN-11 (Lot serial: A1163); Model Catalog: XN-11 (Lot serial: A1161); Model Catalog: XN-11 (Lot serial: A1151); Model Catalog: XN-11 (Lot serial: A1153-A1159); Model Catalog: XN-11 (Lot serial: A1146-A1149); Model Catalog: XN-11 (Lot serial: A1142-A1144); Model Catalog: XN-11 (Lot serial: A1127); Model Catalog: XN-11 (Lot serial: A1130); Model Catalog: XN-11 (Lot serial: A1135-A1140); Model Catalog: XN-10 (Lot serial: 29788-29798); Model Catalog: XN-10 (Lot serial: 29800-29801); Model Catalog: XN-10 (Lot serial: 29803); Model Catalog: XN-10 (Lot serial: 29804); Model Catalog: XN-10 (Lot serial: 11001 - 29656); Model Catalog: XN-10 (Lot serial: 29812); Model Catalog: XN-10 (Lot serial: 29816-29867); Model Catalog: XN-10 (Lot serial: 29668 - 29786); Model Catalog: XN-10 (Lot serial: 29807)
  • Descripción del producto
    XN-11 MODULE;XN-10 MODULE
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    HC