Carmel, IN, United States
SonarMed Inc recalls
3 recalls recorded since 2018, most recently on 25 March 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 25 March 2024
- Reason
- Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
- Distribution
- _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1535-2024
- AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Ongoing Class I Medical devices
- Recall started
- 21 March 2024
- Reason
- The failure to detect the partial obstruction in a 2.5mm sensor.
- Distribution
- Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1521-2024, Z-1519-2024, Z-1520-2024
- AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Terminated Class II Medical devices
- Recall started
- 17 April 2017
- Terminated
- 16 July 2020
- Reason
- Potential for the presence of two error codes which would make the monitor inoperable.
- Distribution
- CA & TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2450-2019
- SonarMed AirWave Monitor, Model Number M0001
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.