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