Recall – Radiology software defect may result in missing images

Company: CHANGE HEALTHCARE CANADA COMPANY
Date of Enforcement Report: 10/14/2020
Class II

PRODUCT

Change Healthcare Radiology Solutions 14.0

Recall Number: Z-0072-2021

REASON

Software defect which may potentially result in one or more images missing in a study.

RECALLING FIRM/MANUFACTURER

CHANGE HEALTHCARE CANADA COMPANY on 8/25/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

5 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
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.