SonarMed recalls AW-M0001 airway monitors that may fail to detect partial obstructions in 2.5mm sensors. Affected units have specific serial numbers. Contact SonarMed for details.
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
SonarMed is recalling its AW-M0001 airway monitors that can fail to detect partial obstructions in 2.5mm sensors. This could lead to missed airway issues during medical monitoring. Affected units have specific serial numbers listed in the recall.
The software anomaly causes the monitor to fail in detecting partial obstructions in 2.5mm sensors and up to 3mm distal to the sensor. This could lead to missed airway issues during medical monitoring if the device is used without proper detection.
Medical professionals using SonarMed AW-M0001 monitors for airway monitoring are most at risk. Patients receiving this monitoring may be affected if the device fails to detect obstructions.
Check for the model number AW-M0001 on the device. Affected units have specific serial numbers listed in the recall (e.g., AW0572, AW0573, etc.). The product is used with SonarMed Acoustic Sensors for airway monitoring.
Look for the serial number on the monitor, which should match the list of affected serial numbers provided in the recall.
The recalled device is the AW-M0001 SONARMED MONITOR.
The software anomaly can cause the monitor to fail in detecting partial obstructions in 2.5mm sensors and up to 3mm distal to the sensor.
Check the serial number against the list of affected serial numbers provided in the recall (e.g., AW0572, AW0573, etc.).
We’ve drafted a message you can send SonarMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1535-2024 — SonarMed SonarMed Hello, I own a SonarMed that is covered by recall Z-1535-2024 from SonarMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
