Fisher & Paykel Healthcare, Ltd. is recalling 944 units of the Airvo 3 Respiratory Support Device (Model PT301US) with software versions 1.2.0 or 1.5.1. A software defect can cause the device to deliver only room air instead of supplemental oxygen if a specific alarm occurs. This device is typically used in hospitals and sub-acute facilities to provide respiratory support for patients ranging from infants to adults. No injuries have been reported in connection with this issue.
If the device delivers room air when a patient requires high-pressure oxygen, the patient may experience low oxygen levels (hypoxia), which can lead to serious health complications or death.
Intended for spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.