SonarMed Inc 2024-04-24 Health critical FDA
Health · FDA · Recall #FDA-Z-1535-2024
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway… Recall
Issued April 24, 2024 · SonarMed Inc
In April 2024, SonarMed Inc recalled the AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
What you should do
- 1 Stop using AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SonarMed Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SonarMed Inc
- Category
- Health
- Recall date
- April 24, 2024
- Units affected
- Not reported
- Sold at
- _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
- Recall number
- FDA-Z-1535-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- SonarMed Inc has 3 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.