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.
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: 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
- Affected units
- 690
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
Part of a larger recall action
This product is one of 3 recalled by SonarMed Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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