SonarMed Recalls
5 recalls on record · September 11, 2019 to April 24, 2024 · Medical Devices
Recalls by year
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Hazard: Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
September 11, 2019Medical DevicesFDA
SonarMed Inc recalls SonarMed AirWave Monitor, Model Number M0001
Hazard: Potential for the presence of two error codes which would make the monitor inoperable.