Airvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall
Fisher & Paykel's Airvo 2 and myAirvo 2 respiratory humidifiers have a speaker defect that may silence or distort critical alarm sounds. If the alarm fails and therapy is interrupted, patients could experience oxygen desaturation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device defect that could lead to serious patient harm (oxygen desaturation) due to alarm malfunction during respiratory therapy. However, no illnesses or injuries have been reported, making this a risk-of-harm scenario where the potential for serious harm exists but has not been realized.
Plain-English summary
Fisher & Paykel Healthcare is recalling approximately 7,147 Airvo 2 Humidifiers (REF: PT101US) and myAirvo 2 Humidifiers (REF: PT100US) that were manufactured before August 14, 2017. These devices deliver high-flow respiratory therapy to patients.
The humidifiers have a speaker configuration defect that may cause alarm sounds to become distorted, intermittent, or inaudible. If an alarm fails to sound when therapy is interrupted, patients could experience oxygen desaturation.
The recalled devices were distributed nationwide across all 50 U.S. states. Patients using these humidifiers should contact Fisher & Paykel Healthcare to verify if their device is affected and to arrange a replacement or repair.
The recalled product
- Product
- Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Affected units
- 7,147
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF/UDI-DI: PT100US/09420012422248
Distribution
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