FDA-Device2024-12-04Class II
Discovery MR750w 3.0T, whole body magnetic resonance scanner
GE Medical Systems, LLC
Hazard
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Sold states
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Affected count
8 units
Manufactured in
3200 N Grandview Blvd, Waukesha, WI, United States
Products
Discovery MR750w 3.0T, whole body magnetic resonance scanner
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0517-2025Don't want to check this manually?
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