SonarMed Inc FDA Recalls

4 recalls on file across devices, 4 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.Class IMar 25, 2024Software anomaly resulted in failure to detect a partial obs	Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to	Class IDevices	Mar 25, 2024
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.Class IMar 21, 2024The failure to detect the partial obstruction in a 2.5mm sen	The failure to detect the partial obstruction in a 2.5mm sensor.	Class IDevices	Mar 21, 2024
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.Class IMar 21, 2024The failure to detect the partial obstruction in a 2.5mm sen	The failure to detect the partial obstruction in a 2.5mm sensor.	Class IDevices	Mar 21, 2024
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.Class IMar 21, 2024The failure to detect the partial obstruction in a 2.5mm sen	The failure to detect the partial obstruction in a 2.5mm sensor.	Class IDevices	Mar 21, 2024