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GE Medical Systems, LLC recalls SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Recalled December 4, 2024 · FDA recall Z-0518-2025 · GE Medical Systems
Hazard
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. · FDA Class II
Units
53 units
Sold at
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
Description
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Product
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →