AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reported: April 24, 2024 Initiated: March 21, 2024 #Z-1519-2024
Product Description
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Reason for Recall
The failure to detect the partial obstruction in a 2.5mm sensor.
Details
- Recalling Firm
- SonarMed Inc
- Units Affected
- 610 units
- Distribution
- Domestic: 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-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.. Recalled by SonarMed Inc. Units affected: 610 units.
Why was this product recalled? ▼
The failure to detect the partial obstruction in a 2.5mm sensor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Critical. Recall number: Z-1519-2024.
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