Recall – Blood gas analyzer software security vulnerability

Company: Radiometer America Inc
Date of Enforcement Report: 8/28/2019
Class II

PRODUCT

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

  • Recall Number: Z-2320-2019

REASON

Software Security; The action is being initiated because of software security vulnerabilities with the firm’s analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

RECALLING FIRM/MANUFACTURER

Radiometer America Inc on 7/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

13,042 units

DISTRIBUTION

US Nationwide and International

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.