Home / Recalls / Medical Devices
GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Recalled October 13, 2021 · FDA recall Z-0012-2022 · GE Healthcare
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). · FDA Class II
Units
49
Sold at
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
Description
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).
Product
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →