Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SIGNA Architect AIR Recalled by GE Medical Systems, LLC Due to GE HealthCare has become aware that gradient coils...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems, LLC directly.
Affected Products
SIGNA Architect AIR
Quantity: N/A
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GE Medical Systems, LLC
GE Medical Systems, LLC has 146 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report