FDA-Device2020-10-28Class II
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
GE Healthcare, LLC
Hazard
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
Affected count
30 Devices total
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0129-2021Don't want to check this manually?
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