SonarMed AirWave AW-M0001Recalls & reported problems
Sonarmed, Inc · AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord, data communication cable, reusable sensor cable, hang strap and software CD. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851334007001), received between Sep 17, 2024 and Sep 17, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (1 report).
3 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Mar 25, 2024Class IOpen, Classified
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Z-1535-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 22, 2021Class IIOpen, Classified
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
Z-0514-2022 · Root cause: Process control · Recall details · FDA record ↗
- Apr 17, 2017Class IITerminated
Potential for the presence of two error codes which would make the monitor inoperable.
Z-2450-2019 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Calibrate1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THIS SONARMED DEVICE HAD MUFFLED SPEAKER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238637 ↗MalfunctionSep 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED THAT, THIS SONARMED DEVICE WAS UNABLE TO CALIBRATE. IT WAS ALSO NOTED THAT THE DEVICE DISPLAYED "CHECK/CHANGE SENSOR" ERROR MESSAGE AFTER TRYING TO DISCONNECT AND RECONNECT THE SENSOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238411 ↗
Other Airway Monitoring System devices
- SonarMed AirWave AW-S030Sonarmed, Inc · Airway Monitoring System1 recall3 reports
- SonarMed AirWave AW-S035Sonarmed, Inc · Airway Monitoring System1 recall1 report
- SonarMed AirWave AW-S025Sonarmed, Inc · Airway Monitoring System1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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