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SonarMed Inc recalls AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Recalled April 24, 2024 · FDA recall Z-1535-2024 · SonarMed
Hazard
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. · FDA Class I
Units
145 units
Sold at
_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
Description
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Product
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Manufacturer(s)
SonarMed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →