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

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
to receive discount

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.