Events

Recall of ARTIS DIALYSIS SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER CORPORATION.

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
    38434
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-14
  • 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
    There have been reports of a burning smell/smoke coming out from the upper ventilation grids of the artis dialysis machine. the events have been associated with a limited number of power supply units manufactured with a specific batch of capacitor. the technical analysis identified that the issue was caused by a defective capacitor inside the power supply unit which has the potential to melt after approximatively 4 years of use.

Device

ARTIS DIALYSIS SYSTEM
  • Model / Serial
    Model Catalog: 112949 (Lot serial: > 100 NUMBERS CONTACT MFG)
  • Product Description
    ARTIS DIALYSIS SYSTEM
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION