Recall Z-3262-2024— Fisher & Paykel Healthcare, Ltd.
Class II · Ongoing
Class II FDA medical device recall by Fisher & Paykel Healthcare, Ltd., initiated 2024-08-07. It names one FDA 510(k) clearance: K221338. Product: PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.. Reason: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia..
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-07
- Firm location
- Auckland, 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
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Reason for recall
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.