Events

Recall of Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

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
    RC-2017-RN-00494-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00494-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Baxter healthcare is issuing a device correction for specific models of the artis dialysis systems in order to update the current software versions to the 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 detailed in the operator’s manual. users of these devices should adhere to the instructions provided in the current operator’s manual for addressing alarm #642.
  • Action
    Clinicians may continue to safely use the affected Artis dialysis systems provided they utilise additional vigilance to adhere to the instruction for use for addressing Alarm #642, as documented in the Operator’s Manual until the software correction can be provided to the relevant facilities.

Device

Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio I
  • Model / Serial
    Artis Dialysis Systems - 230V, 230V Physio & 230 V Physio IProduct Codes: 110635, 115323 and 115147All Serial NumbersARTG Number: 141189
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd