Retiro De Equipo (Recall) de 2008T HEMODIALYSIS SYSTEM CDX

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por FRESENIUS MEDICAL CARE 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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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 correction of 10 machines at a customer site was required because they were installed with an unapproved version of software (v 2.30) preloaded on the function board. the version that was installed is approved in the united states but has not yet been reviewed and approved by health canada. the newest version is very similar to the currently approved version (v2.13) but does include a change to the user interface and as such requires a class 3 amendment to the licence before sale in canada. due to the similarity between the two versions the error was not immediately noticeable to the user or patients and thus not observed when the first machines were installed and put in use on wednesday april 11 2012.


  • Modelo / Serial
    Model Catalog: 190713 (Lot serial: 2TOS110728); Model Catalog: 190713 (Lot serial: 2TOS110705); Model Catalog: 190713 (Lot serial: 2TOS110694); Model Catalog: 190713 (Lot serial: 2TOS110680); Model Catalog: 190713 (Lot serial: 1TOS108806); Model Catalog: 190713 (Lot serial: 2TOS110683); Model Catalog: 190713 (Lot serial: 2TOS110771); Model Catalog: 190713 (Lot serial: 2TOS110747); Model Catalog: 190713 (Lot serial: 2TOS110744); Model Catalog: 190713 (Lot serial: 2TOS110522)
  • Descripción del producto
  • Manufacturer