AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Reported: April 24, 2024 Initiated: March 25, 2024 #Z-1535-2024
Product Description
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
Reason for Recall
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Details
- Recalling Firm
- SonarMed Inc
- Units Affected
- 145 units
- Distribution
- _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_
- Location
- Carmel, IN
Frequently Asked Questions
What product was recalled? ▼
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.. Recalled by SonarMed Inc. Units affected: 145 units.
Why was this product recalled? ▼
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Critical. Recall number: Z-1535-2024.
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