FDA-Device2014-11-19Class II

OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures

GE OEC Medical Systems, Inc
Hazard

GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.

Sold states
Worldwide Distribution.
Affected count
2
Manufactured in
384 Wright Brothers Dr, Salt Lake City, UT, United States
Products
OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0192-2015

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