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GE Healthcare, LLC recalls SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Recalled October 27, 2021 · FDA recall Z-0137-2022 · GE Healthcare
Hazard
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. · FDA Class II
Units
6 devices
Sold at
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
Description
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
Product
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →