FDA-Device2014-11-19Class II
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
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
26
Manufactured in
384 Wright Brothers Dr, Salt Lake City, UT, United States
Products
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2015Don't want to check this manually?
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