SonarMed Airway Monitoring Sensor Fails to Detect Partial Obstruction
SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of a medical device with a critical safety function failure—inability to detect airway obstruction. No illnesses or deaths are reported in the source, but the potential for serious harm from undetected airway obstruction justifies a Severe rating per the Class I classification criterion.
Plain-English summary
SonarMed Inc has recalled the AW-S030 NEO SONARMED SENSOR 3.0MM, a medical device used for airway monitoring in conjunction with the SonarMed Monitor. The recall affects 690 units with specific serial numbers that were distributed domestically to 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 sensor fails to detect partial airway obstruction during operation. This detection failure could prevent clinical identification of a critical airway condition, potentially leading to serious patient harm or death.
Healthcare facilities and clinicians using this product should stop use immediately and check their inventory against the provided serial numbers (A20221012 through A20230317). Contact SonarMed Inc for instructions on device replacement or removal from service. If you have used the recalled sensor and have questions about patient safety, consult with your institution's medical and quality assurance staff.
The recalled product
- Product
- AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
- Manufacturer
- SonarMed Inc
- Hazard
- sensor-malfunction
- detection-failure
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)
- Product Number/CFN: AW-2030
- UDI-DI: 10851334007190
- Serial Numbers: A20221012
- A20221017
- A20221024
- A20221103
- A20221115
- A20221116
- A20221117
- A20221118
- A20221130
- A20221206
- A20221222
- A20221228
- A20221229
- A20230104
- A20230111
- A20230116
- A20230117
- A20230118
Distribution
Distributed in 19 states:
- AK
- AZ
- CA
- FL
- IL
- KY
- MD
- MO
- NC
- NJ
- NY
- OH
- OR
- PA
- SC
- TN
- TX
- VA
- WA
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