FDA Recall: Software Issue Resulting in Failure to Detect Obstruction

Company: SonarMed Inc
Date of Enforcement Report: April 19, 2024
Class I

PRODUCT

AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

Recall Number:

Z-1426-2024

REASON:

SonarMed Inc. is recalling the SonarMed Airway monitoring system because of a software issue resulting in failure to detect a partial obstruction within 2.5mm sensors and extending up to 3mm distal to the sensor tip.

The use of the affected syringe may cause serious adverse health consequences, including delays in treatment, accidental insertion into the bronchial tube, lower oxygen levels (hypoxia), air leaking into the chest cavity (pneumothorax), not enough air reaching the lungs (hypoventilation), harm to the tissues, slow heart rate (bradycardia), or even breathing problems leading to respiratory failure.

There have been no reported injuries or death.

RECALLING FIRM/MANUFACTURER:

SonarMed Inc

VOLUME OF PRODUCT IN COMMERCE:

145

DISTRIBUTION:

AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA

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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