FDA-Device2022-04-13Class II
SIGNA Excite 3T. Magnetic Resonance Imaging System
GE Healthcare, LLC
Hazard
There is potential for the images to be flipped left to right.
Sold states
Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Affected count
55 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
SIGNA Excite 3T. Magnetic Resonance Imaging System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0859-2022Don't want to check this manually?
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