FDA-Device2024-12-04Class II
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
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
2 units
Manufactured in
3200 N Grandview Blvd, Waukesha, WI, United States
Products
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2025Don't want to check this manually?
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