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myAIRVO 1 and AIRVO 2 Humidifier (2016-06-27)
- Starting date:
- June 27, 2016
- Posting date:
- July 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-59462
Affected products
- MYAIRVO 2 HUMIDIFIER
- AIRVO 2 HUMIDIFIER
Reason
User instructions have been updated to include a warning for the user to check speaker functionality before each patient use. This warning points to the speaker functionality check contained in all AIRVO 2/myAIRVO 2 is not intended for life support.
Affected products
A. MYAIRVO 2 HUMIDIFIER
Lot or serial number
All lots
Model or catalog number
PT100US
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND
B. AIRVO 2 HUMIDIFIER
Lot or serial number
All lots
Model or catalog number
PT101US
Companies
- Manufacturer
-
Fisher and Paykel Healthcare Ltd.
15 Maurice Paykel Place East Tamaki, P.O. Box 14348 Panmure
Auckland
2013
NEW ZEALAND