SonarMed Inc. is recalling 145 units of the AW-M0001 SonarMed Monitor, which is used with acoustic sensors to monitor a patient's breathing tube. A software anomaly can cause the device to fail to detect partial blockages in 2.5 mm sensors and obstructions located up to 3mm away from the sensor. This failure means medical staff may not be alerted to life-threatening airway blockages in critically ill patients. This recall affects various serial numbers distributed across 19 states including California, Florida, New York, and Texas.
A software error prevents the monitor from identifying partial blockages in the airway tube, which could lead to restricted airflow or complete respiratory failure if medical providers are not alerted to clear the obstruction. No specific injuries have been reported in the current data, but the failure to detect these blockages in small-diameter sensors poses a critical risk to patient safety.
Manufacturer correction or technical support
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.