Day

July 16, 2003
16
Jul

Inc. Class II Draeger Medical

July 16, 2003
Company: Draeger Medical, Inc.Date of Enforcement Report: 7/16/03 Class: II PRODUCT Evita 4 Continuous Ventilator. Catalog numbers 4116640 and 8412980. Recall # Z-0954-03. REASON Software problems – ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm. CODE Software version 4.00 or 4.10. RECALLING FIRM/MANUFACTURER Draeger Medical, Inc., Telford, PA,...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.