GE Medical Systems recalls SIGNA Architect AIR MRI gradient coils that may produce excessive noise (over 99dB) during scans, exceeding safe hearing levels without proper protection.
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 recalls SIGNA Architect AIR MRI gradient coils that can produce noise over 99dB during scans. This exceeds safe hearing levels without proper hearing protection, potentially causing hearing damage.
Gradient coils in certain MRI systems can generate loud acoustic noise during scans. When this noise exceeds 99dB, it can cause hearing damage if hearing protection with a Noise Reduction Rating (NRR) of :29dB is not used.
Users of SIGNA Architect AIR MRI systems with the affected gradient coils. MRI technicians and patients undergoing scans are most at risk of hearing damage.
Check for SIGNA Architect AIR MRI gradient coils with GTIN: 00195278283481. The product was sold by GE Medical Systems.
Listen for loud noises during MRI scans that may exceed 99dB, indicating potential risk.
GE HealthCare has become aware that gradient coils for certain MR systems can produce elevated acoustic noise during scanning, potentially exceeding safe hearing levels without proper protection.
Acoustic levels can exceed 99dB, which exceeds the safe limit when using hearing protection with a Noise Reduction Rating (NRR) of 29dB.
The recalled product is SIGNA Architect AIR MRI gradient coils with GTIN: 00195278283481.
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-2131-2025 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-2131-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
