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SonarMed AirWave
SONARMED, INC · Model AW-S075 · UDI-DI 00851334007261
OQU
Prescription
3
510(k) clearances
7
Adverse events
6
Recalls
2
Facilities
Description
Adult SonarMed Sensor - for use with endotracheal tubes of 7.5 or 8.0 mm ID
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-25 | SonarMed Inc | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. |
| 2024-03-21 | SonarMed Inc | The failure to detect the partial obstruction in a 2.5mm sensor. |
| 2024-03-21 | SonarMed Inc | The failure to detect the partial obstruction in a 2.5mm sensor. |
| 2024-03-21 | SonarMed Inc | The failure to detect the partial obstruction in a 2.5mm sensor. |
| 2021-12-22 | Covidien, LP | Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monit |
| 2017-04-17 | SonarMed Inc | Potential for the presence of two error codes which would make the monitor inoperable. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.