FDA Recall: Software Issue Resulting in Failure to Detect Obstruction

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.