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