Company: GE Healthcare, LLC
Date of Enforcement Report: 7/25/2022
Centricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
GE Healthcare, LLC
VOLUME OF PRODUCT IN COMMERCE
Worldwide distribution – US Nationwide distribution in the states of CO, NV, OH, PA, WA and the countries of Brazil, Canada, China, France, Germany, Israel, Italy, Japan, Oman, Spain, Switzerland, and United Kingdom.