GE Medical Systems recalls SIGNA Architect MRI gradient coils that can produce loud noise over 99dB during scans, potentially exceeding hearing protection limits. Affected units have specific GTINs listed in the recall notice.
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.
GE Medical Systems is recalling SIGNA Architect MRI gradient coils that can produce loud noise exceeding 99dB during scans. This may exceed hearing protection limits, especially when using hearing protection with a Noise Reduction Rating of :29dB.
Gradient coils in certain SIGNA Architect MRI systems can generate acoustic noise levels above 99dB during scans. This exceeds the safe limit for hearing protection (NRR 29dB) as defined by IEC 60601-2-33 standards, potentially causing hearing damage with prolonged exposure.
Users of SIGNA Architect MRI systems with specific gradient coils. Medical professionals who operate these systems are most at risk due to potential hearing damage from prolonged exposure to high noise levels.
Check for SIGNA Architect MRI systems with gradient coils that have the GTINs listed: 00840682147095, 00840682122702, 00195278023643, or 00840682123440.
Verify if your SIGNA Architect MRI system has one of the listed GTINs: 00840682147095, 00840682122702, 00195278023643, or 00840682123440.
GE HealthCare has become aware that gradient coils for certain SIGNA Architect MRI systems can produce elevated acoustic noise during scanning, potentially exceeding hearing protection limits.
Acoustic levels can exceed 99dB, which exceeds the safe limit for hearing protection (NRR 29dB) as defined by IEC 60601-2-33 standards.
Check if your SIGNA Architect MRI system has one of the listed GTINs: 00840682147095, 00840682122702, 00195278023643, or 00840682123440.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2130-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2130-2025 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
