Company: GE Healthcare, LLC
Date of Enforcement Report: 7/25/2022
Class II
PRODUCT
Centricity PACS Software Version 7.0 SP0.0.4.7
Recall Number:
Z-1466-2022
REASON
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC
VOLUME OF PRODUCT IN COMMERCE
47 installations
DISTRIBUTION
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.
