Recall – Enterprise viewer image styles incorrectly displayed

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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
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USA
+1-781-721-2921
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