FDA-Device2021-10-13Class II
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
GE Healthcare, LLC
Hazard
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
Sold states
AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom
Affected count
49
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2022Don't want to check this manually?
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