Medical DeviceApr 24, 2024
SonarMed AW-M0001 SONARMED MONITOR recall — FDA Z-1535-2024
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
Class IFDA: OngoingSonarMed Inc.
Recall history in this database
Classification mix: Class I: 4.
Medical DeviceApr 24, 2024
SonarMed AW-S035 NEO SONARMED SENSOR 3.5MM recall — FDA Z-1521-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
SonarMed AW-S025 NEO SONARMED SENSOR 2.5MM recall — FDA Z-1519-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Medical DeviceApr 24, 2024
SonarMed AW-S030 NEO SONARMED SENSOR 3.0MM recall — FDA Z-1520-2024
The failure to detect the partial obstruction in a 2.5mm sensor.
Class IFDA: OngoingSonarMed Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies SonarMed Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.