Recall Z-2450-2019— SonarMed Inc

Name: FDA recall Z-2450-2019
Creator: U.S. Food and Drug Administration
Published: 2017-04-17

Class II · Terminated

Class II FDA medical device recall by SonarMed Inc, initiated 2017-04-17, terminated 2020-07-16. It names one FDA 510(k) clearance: K143042. Product: SonarMed AirWave Monitor, Model Number M0001. Reason: Potential for the presence of two error codes which would make the monitor inoperable..

Recalling firm: SonarMed Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Terminated: 2020-07-16
Firm location: Carmel, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K143042 — SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc.·cleared 2016-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SonarMed AirWave Monitor, Model Number M0001

Reason for recall

Potential for the presence of two error codes which would make the monitor inoperable.

Data sourced from openFDA. This site is unofficial and independent of the FDA.