GE Medical Systems, LLC recalls SIGNA Architect

Recall date

May 23, 2025

Source

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

Recall number

Z-2130-2025

FDA classification

Class II

Brand / firm

GE Medical Systems, LLC

Sold / distributed

Worldwide distribution - US Nationwide and the country of China.

Why it was recalled

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

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