FDA-Device2022-08-03Class II
Centricity PACS Software Version 7.0 SP0.0.4.7
GE Healthcare, LLC
Hazard
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
Sold states
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.
Affected count
47 installations
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity PACS Software Version 7.0 SP0.0.4.7
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2022Don't want to check this manually?
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