Events

Recall of AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fisher & Paykel 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-00729-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00729-1
  • 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
    Fisher & paykel has updated the airvo 2 / myairvo 2 user instructions to include a check that the speaker is audible prior to each patient use in order to ensure the speaker is functioning.
  • Action
    Fisher & Paykel are advising users that the AIRVO 2 / myAIRVO 2 User Instructions have been updated to include a warning for the user to check speaker functionality before each patient use, using the steps in the User Instructions. First turn the unit on and then remove the heated breathing tube. The user should see the “check tube” visual signal and hear the speaker signal. If either signal is absent, users are advised not to use the unit and contact their Fisher & Paykel representative to arrange for a replacement device.

Device

AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
  • Model / Serial
    AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 HumidifierModel Number: PT101XXmyAIRVO 2 HumidifierModel Number: PT100XXAffected Serial Numbers: 120521YYYYYY – 160605YYYYYYARTG Number: 177298
  • Manufacturer
    Fisher & Paykel Healthcare Pty Ltd

Manufacturer

Fisher & Paykel Healthcare Pty Ltd