SonarMed recalls AW-S035 NEO SONARMED SENSOR 3.5MM used with airway monitors due to failure to detect partial obstructions in 2.5mm sensors. Affected units have specific serial numbers and were sold starting in 2022.
The failure to detect the partial obstruction in a 2.5mm sensor.
SonarMed is recalling its AW-S035 NEO SONARMED SENSOR 3.5MM for airway monitoring. The sensor may fail to detect partial obstructions in the airway, which could lead to serious health risks if not properly monitored.
The sensor may fail to detect partial obstructions in the airway, which could lead to serious health risks if the monitoring system is not functioning properly. This is a critical issue for patients requiring continuous airway monitoring.
Healthcare professionals using the sensor with SonarMed Monitor for airway monitoring are most at risk. Patients relying on this monitoring system could be affected if the sensor fails.
Check for serial numbers starting with A20221012 through A20230307 on the product label. The sensor is used with SonarMed Monitor for airway monitoring and was sold starting in 2022.
Look for serial numbers starting with A20221012 through A20230307 on the sensor label.
The sensor may fail to detect partial obstructions in the airway, which could lead to serious health risks if not properly monitored.
Check the serial number on the product label. If it starts with A20221012 through A20230307, contact SonarMed for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send SonarMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1521-2024 — SonarMed SonarMed Hello, I own a SonarMed that is covered by recall Z-1521-2024 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.
