Company: CHANGE HEALTHCARE CANADA COMPANY
Date of Enforcement Report: 6/9/2021
Class II

PRODUCT

Change Healthcare Enterprise Viewer – Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

Recall Number: Z-1773-2021

REASON

A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.

RECALLING FIRM/MANUFACTURER

CHANGE HEALTHCARE CANADA COMPANY on 4/19/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

33 devices

DISTRIBUTION

U.S. Nationwide