SIGNA Architect AIR
FDA Recall #Z-2131-2025 — Class II — May 23, 2025
Product Description
SIGNA Architect AIR
Reason for Recall
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.
Recalling Firm
GE Medical Systems, LLC — Waukesha, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
Worldwide distribution - US Nationwide and the country of China.
Code Information
GTIN: 00195278283481
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated