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GE Healthcare, LLC recalls Centricity PACS Software Version 7.0 SP0.0.4.7
Recalled August 3, 2022 · FDA recall Z-1466-2022 · GE Healthcare
Hazard
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. · FDA Class II
Units
47 installations
Sold at
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.
Description
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Product
Centricity PACS Software Version 7.0 SP0.0.4.7
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →