FDA recall Z-1535-2024

Product

AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.

Reason for recall

Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.

Distribution

_AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_

Key facts

Status

Ongoing

Initiation date

2024-03-25

Report date

2024-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Carmel, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2024