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Recall Observatory FDA recall evidence

Device product

AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.

Z-1520-2024

March 21, 2024

Class I

Product summary

Firm
SonarMed Inc
Event
Event 94292
Status
Ongoing
Classification
Class I
Quantity
690 units
Official record key
device-enforcement:Z-1520-2024

Official wording

Reason: The failure to detect the partial obstruction in a 2.5mm sensor.

Code information: 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, A20230208, A20230209, A20230313, A20230314, A20230315, A20230316, A20230317, A20230405.

Distribution pattern: Domestic: AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The failure to detect the partial obstruction in a 2.5mm sensor.