Medical Device Airway Monitor Software Defect Prevents Obstruction Detection
A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall meets FDA Class I criteria, which mandates a minimum severity score of 4. The software defect creates a risk of undetected airway obstruction in critical care settings, where failure to alert clinicians to breathing compromise could have serious consequences.
Plain-English summary
The SonarMed AW-M0001 Monitor is a medical device used with acoustic sensors to monitor airway patency in patients. A software anomaly prevents the device from detecting partial airway obstructions in 2.5mm sensors and larger, as well as obstructions occurring up to 3mm distal (beyond) the sensor location.
Approximately 145 units of the AW-M0001 have been distributed across 19 states including Alaska, Arizona, California, Florida, Illinois, Kentucky, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Washington. The specific affected serial numbers range from AW0572 through AW0855 with selective gaps.
Healthcare facilities should contact SonarMed regarding available software updates to resolve the detection anomaly. Clinicians should remain aware that the affected devices may not reliably detect airway obstructions in the specified range and should employ additional clinical assessment methods to ensure patient safety. Patients should not discontinue monitoring without consulting their healthcare provider.
The recalled product
- Product
- AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
- Manufacturer
- SonarMed Inc
- Affected units
- 145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. AW-M0001
- GTIN: 00851334007001
- Serial No. AW0572
- AW0573
- AW0574
- AW0577
- AW0578
- AW0579
- AW0580
- AW0581
- AW0584
- AW0585
- AW0586
- AW0588
- AW0591
- AW0593
- AW0594
- AW0600
- AW0606
- AW0607
Distribution
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