Events

Recall of Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Resmed 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-2016-RN-00050-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00050-2
  • 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
    Astral devices may experience an issue when powered by an external battery (astral external battery or rps ii). the issue can prevent the user from powering on the device after the auto power off feature powers off the device when there has been no user interaction with the device for 15 minutes and the ventilator is in stand-by.The external battery start up issue only affects astral 100 and astral 150 devices with sr1.1 software (sx544-0301).
  • Action
    ResMed is advising users to contact ResMed technical support to arrange for the installation of a software upgrade which will address the reported issue. Please note that this software upgrade (SX544-0401) addresses the circuit disconnection alarm issue reported previously (RC-2015-RN-00391-1) as well as the external battery power issue reported in this current recall notification. This action has been closed-out on 05/09/2016.

Device

Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)
  • Model / Serial
    Astral Ventilators - ResMed Astral 100 & Astral 150 with SR1.1 software (SX544-0301)Product Codes 27081 and 27083ARTG Number: 219429
  • Manufacturer
    Resmed Limited

Manufacturer

Resmed Limited