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

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

An Urgent Medical Device Recall notification dated 3/25/2024 was mailed to consignees via UPD notifying them of this SonarMed Sensor and Monitor recall. Consignees were asked to discontinue use of affected devices, quarantine any affected devices, and return all quarantined devices to Medtronic by obtaining a Returned Goods Authorization (RGA) from [email protected]. If product was purchased through a distributor the distributor can arrange for return. The provided notification is to be provided to those within consignee organizations that need to be made aware and if product was further distributed. Consignees with questions are to contact customer service at 800-962-9888, Option 2.