FDA-Device2012-08-29Class II
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
GE OEC Medical Systems, Inc
Hazard
X-ray units did not meet manufacturer's specification for linearity.
Sold states
Worldwide Distribution - USA - Australia, Brazil, Cameroon, China, Colombia, Cyprus, The Czech Republic, Finland, France, Germany, Greece, Italy, Japan, Korea, Malaysia, The Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Taiwan, Turkey, UAE, UK, and Canada.
Affected count
175 units
Manufactured in
384 Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2221-2012Don't want to check this manually?
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