FDA-Device2024-04-24Class I
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed Inc
Hazard
The failure to detect the partial obstruction in a 2.5mm sensor.
Sold states
Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.
Affected count
690 units
Manufactured in
12220 N Meridian St Ste 150, Carmel, IN, United States
Products
AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2024Don't want to check this manually?
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