25
Sep
2024

FDA Recall: Software Issue May Lead to Room Air Only Rather than HPO

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Company: Fisher & Paykel Healthcare, Ltd.
Date of Enforcement Report: 9/25/2024
Class II

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.

Recall Number:

Z-3262-2024

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/MANUFACTURER:

Fisher & Paykel Healthcare, Ltd.

VOLUME OF PRODUCT IN COMMERCE:

944 units

DISTRIBUTION:

U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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