Recall Z-1520-2024— SonarMed Inc
Class I · Ongoing
Class I FDA medical device recall by SonarMed Inc, initiated 2024-03-21. Product: AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.. Reason: The failure to detect the partial obstruction in a 2.5mm sensor..
- Recalling firm
- SonarMed Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-03-21
- Firm location
- Carmel, IN, United States
Product description
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason for recall
The failure to detect the partial obstruction in a 2.5mm sensor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.