Recall – Enterprise viewer fails intermittently

Company: Change Healthcare Canada Company
Date of Enforcement Report: 5/5/2021
Class II

PRODUCT

Change Healthcare Enterprise Viewer

Recall Number: Z-1508-2021

REASON

Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.

RECALLING FIRM/MANUFACTURER

Change Healthcare Canada Company on 3/17/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

28 units

DISTRIBUTION

U.S. Nationwide

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.