Recall Z-1535-2024— SonarMed Inc
Class I · Ongoing
Class I FDA medical device recall by SonarMed Inc, initiated 2024-03-25. Product: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.. Reason: Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor..
- Recalling firm
- SonarMed Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-25
- Firm location
- Carmel, IN, United States
Product description
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Reason for recall
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.