FDAOctober 28, 2024device

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems

UPCs

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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