medical Class II Updated 2021-10-13

GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiolo

Recalled Product

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Hazard / Issue

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).

Issued by

FDA

Affected States: AR, IL, ME, MS, NE, NJ, NY, TN
Lot/Code Info: Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
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