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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00729-1
Product Name/Description	AIRVO 2 / myAIRVO 2 Humidifier AIRVO 2 Humidifier Model Number: PT101XX myAIRVO 2 Humidifier Model Number: PT100XX Affected Serial Numbers: 120521YYYYYY – 160605YYYYYY ARTG Number: 177298
Recall Action Level	Retail
Recall Action Classification	Class III
Recall Action Commencement Date	8/06/2016
Responsible Entity	Fisher & Paykel Healthcare Pty Ltd
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	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. This action has been closed out on the 12/10/2018.
Contact Information	03 9879 5022 - Fisher & Paykel Healthcare