SonarMed

Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

The failure to detect the partial obstruction in a 2.5mm sensor.

The failure to detect the partial obstruction in a 2.5mm sensor.

The failure to detect the partial obstruction in a 2.5mm sensor.

Potential for the presence of two error codes which would make the monitor inoperable.