Events

Recall of Concerto & Basic Shower Trolleys (used for assisted hygiene care)

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-2016-RN-00500-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00500-1
  • 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
    As part of post market surveillance (complaint reporting) monitoring, arjohuntleigh received a limited number of complaints where the bolts under the stretcher became loose. there has been one minor injury as a result of a patient falling related to these incidents. arjohuntleigh investigated the issue and concluded the stretcher mounting bolts or stretcher tilting mechanism can become loose which may make the device unstable, providing a potential for risk to the patient or the caregiver. there is a risk the locking mechanism for the stretcher–tilt function may not engage properly, resulting in a patient falling to the floor.
  • Action
    ArjoHuntLeigh is advising users to ensure the trolleys are checked regularly as per the Instructions for Use (IFU). ArjoHuntLeigh will be performing an inspection on all affected devices to ensure the bolts are securely fastened. This action has been closed-out on 16/02/2017.

Device

Concerto & Basic Shower Trolleys (used for assisted hygiene care)
  • Model / Serial
    Concerto & Basic Shower Trolleys (used for assisted hygiene care)Serial Numbers: 3000846870, 3000852015, 3000856697, 3000856697, 3000856697, 3000646121, 3000674706, 3000674706, 3000676859, 3000674706,3000717577, 3000717577, 3000720597, 3000720597, 3000756366, 3000766008, 3000783964, 3000783964, 3000783964 Manufactured between 7 March 2014 and 20 April 2015ARTG Number: 199958
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

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