Recall Z-1823-2024— Fisher & Paykel Healthcare, Ltd.
Class II · Ongoing
Class II FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2024-04-02. It names one FDA 510(k) clearance: K131895. Product: Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US. Reason: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation..
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-02
- Firm location
- Auckland, N/A, New Zealand
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Reason for recall
Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.