Day

May 8, 2002
Company: Sigma International MedinaDate of Enforcement Report: 5/8/02 Class: II PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R,...
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
Partners located in the US (CA, FL, MA, MN, TX) and Canada.