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

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.