The Recall Desk
HighFDA (Devices)·Z-3262-2024·Announced 2024-10-02

Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery

Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.

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: FDA Class II medical device with a software defect that poses risk of oxygen desaturation and hypoxia in respiratory support patients. The source text does not report any illnesses or injuries, making this a potential rather than realized harm scenario, qualifying it as High severity per the rubric.

Plain-English summary

Fisher & Paykel Healthcare's Airvo 3 Respiratory Support Device (Model PT301US, software versions 1.2.0 and/or 1.5.1) is being recalled due to a software defect.

The device is designed to deliver high-flow warmed and humidified respiratory gases to spontaneously breathing patients of all ages—from infants to adults—in hospital and sub-acute care settings. When the device is configured with High Pressure Oxygen (HPO) and a flow alignment alarm occurs, the device will deliver only room air instead of the prescribed oxygen. This failure could cause oxygen desaturation and hypoxia, serious respiratory complications.

A total of 944 units have been distributed across the United States in the following states: Arizona, California, Colorado, Connecticut, Washington DC, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, and Washington.

Patients and healthcare facilities should contact Fisher & Paykel Healthcare for instructions regarding affected devices. The FDA has classified this as a Class II recall.

The recalled product

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
Manufacturer
Fisher & Paykel Healthcare, Ltd.
Category
Medical Device — Respiratory Support
Hazard
  • oxygen-desaturation
  • hypoxia
  • software-defect

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)

  • Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:

Distribution

Distributed in 29 states:

  • 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
  • WA

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