Events

Recall of 2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FRESENIUS MEDICAL CARE CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36778
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The purpose of this recall is to inform users of the 2008 series hemodialysis machines of a software issue pertaining to the ultrafiltration rate (uf) during treatment. it was discovered that when the uf rate goal or time is adjusted using the "up" and "down" arrow keys of the hemodialysis machine and the change is cancelled using the "escape" key without pressing the "confirm" key first the "cancelled" uf rate is actually being executed rather than the rate displayed on the machine.

Device

2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED
  • Model / Serial
    Model Catalog: RTLR190573 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190729 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190653 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190766 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190713 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190908 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190395 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190713 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190395 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 191014 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190766 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190630 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190610 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190301 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190302 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog:
  • Product Description
    2008T Hemodialysis System CDX - Refurbished;Fresenius 2008T Hemodialysis System;Fresenius 2008K2@Home;Fresenius 2008T Hemodialysis System CDX;K@Home;Fresenius 2008K2 Dialysate Delivery System;2008K@Home - Refurbished;Fresenius 2008K Dialysate Delivery Sys
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.