Events

Recall of PHOENIX HEMODIALYSIS DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GAMBRO DASCO S.P.A..

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
    127773
  • Event Risk Class
    I
  • Event Initiated Date
    2002-04-26
  • 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
    Possibility of a failure of an electronic component in the phoenix conductivity monitorng system which may cause incorrect measurement of the dialysate conductivity.

Device

PHOENIX HEMODIALYSIS DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: 6022933700 (Lot serial: C/N PH0839); Model Catalog: 6022933700 (Lot serial: FILE # QSG 026/02-EP); Model Catalog: 6022933700 (Lot serial: ESTAB LIC # 104749); Model Catalog: 6022933700 (Lot serial: DEV LIC # 27646)
  • Product Description
    PHOENIX HEMODIALYSIS SYSTEM
  • Manufacturer
    GAMBRO DASCO S.P.A.

Manufacturer

GAMBRO DASCO S.P.A.