Events

Recall of BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ARJO Hospital Equipment Pty Limited.

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-2013-RN-00398-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00398-1
  • 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
    There have been reports of patients inadvertently placing the system into a pseudo-exit position when using the hand control pendant.
  • Action
    Customers are requested to remove the hand pendant from use on all BariAir Therapy Systems. If removal of the hand pendant is not possible it is recommended that patient positioning is regularly inspected. A new hand pendant has been developed. ArjoHuntleigh will contact their customers to coordinate the replacement of the hand pendant.

Device

BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion,...
  • Model / Serial
    BariAir Therapy System (Provides low air-loss pressure management therapy, pulsation, percussion, turn-assist, flexible patient positioning capabilities and built-in scales for large patients)Model Number: 404000Affected Serial Numbers: BKIK00570, BKIK00565 and BKIK00563Supplied previously in Australia by KCI Medical Australia Pty Ltd under ARTG# 176118
  • Manufacturer
    ARJO Hospital Equipment Pty Limited

Manufacturer

ARJO Hospital Equipment Pty Limited
  • Source
    DHTGA