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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.