Recall – Airway monitoring system software error can lead to inoperable monitor

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

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