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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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