GE Medical Systems, LLC recalls SIGNA Architect, Nuclear Magnetic Resonance Imaging System

Recall date

October 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0518-2025

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

Why it was recalled

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SIGNA Architect, Nuclear Magnetic Resonance Imaging System