Company: SonarMed Inc
Date of Enforcement Report: 9/11/2019
Class II
PRODUCT
SonarMed AirWave Monitor, Model Number M0001
- Recall Number: Z-2450-2019
REASON
Potential for the presence of two error codes which would make the monitor inoperable.
RECALLING FIRM/MANUFACTURER
SonarMed Inc. on 4/17/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
US Nationwide