Events

Recall of ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Huntleigh 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-00786-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00786-1
  • 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
    Arjohuntleigh has identified that in some instances specific acs900 pumps will constantly deliver pressure to the garment without triggering the alarm. an investigation has concluded that the consistent flow of pressure to the garment without deflation may lead to a potential risk of injury to patients. arjohuntleigh has received a limited number of complaints regarding this specific state.
  • Action
    ArjoHuntleigh is requesting that customers: 1. Ensure that all caregivers and users of the ArjoHuntleigh Flowtron ACS900 pump are made aware of this recall for product correction and that all listed devices at their facility are available to be upgraded during the service technician visit; 2. Complete, sign and return the Customer Response Form to ArjoHuntleigh. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to upgrade the software on all listed devices, free of charge.

Device

ArjoHuntleigh Flowtron ACS900 Active Compression System Flowtron ACS900 pumps manufactured betwee...
  • Model / Serial
    ArjoHuntleigh Flowtron ACS900 Active Compression SystemFlowtron ACS900 pumps manufactured between 26 Sept 2014 and 20 Dec 2016 with software V1.099Serial Number range: 1400028031 to 1600048470ARTG Number: 254916
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA