FDA-Device2021-10-27Class II
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
GE Healthcare, LLC
Hazard
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Sold states
Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
Affected count
6 devices
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2022Don't want to check this manually?
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