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