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
    23572
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-03
  • 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
    Baxter corporation is issuing a device correction for the artis dialysis system in order to update the current software versions to new software versions. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642 "arterial chamber: level adjustment required." this will subsequently deactivate the alarm for the remaining treatment time. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642 as written in the operator's manual.

Device

ARTIS DIALYSIS SYSTEM
  • Model / Serial
    Model Catalog: 112949 (Lot serial: all serial numbers)
  • Product Description
    Artis Dialysis System
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION