Lower riskMedical device recall · FDA · Published May 23, 2025
GE SIGNA Architect MRI gradient coils may cause loud noise exceeding 99dB
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.
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Contact the company
📍Recalling firmGE Medical Systems, LLC3200 N Grandview Blvd · Waukesha, WI 53188-1693
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/52217-ge-signa-architect-mri-gradient-coils-may-cause-loud-noise.
“GE SIGNA Architect MRI gradient coils may cause loud noise exceeding 99dB.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52217-ge-signa-architect-mri-gradient-coils-may-cause-loud-noise. Based on FDA recall #Z-2130-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2130-2025%22&limit=1).
The FDA announced on May 23, 2025, that GE Medical Systems, LLC is recalling SIGNA Architect magnetic resonance systems due to elevated acoustic noise hazards. The company initiated this voluntary Class II recall after discovering gradient coils can produce noise exceeding regulatory limits under specific conditions.
How to tell if you have it
SIGNA Architect
UPC 00840682147095
UPC 0682122702
The hazard
According to the FDA, gradient coils for certain MR systems can produce elevated acoustic noise during scanning under specific conditions. This noise can exceed 99dB, which is the limit established by the International Electrotechnical Commission when using hearing protection with a Noise Reduction Rating of 29dB.
Context
GovInfoNow's records show GE Medical Systems, LLC has 27 other recalls on record since March 30, 2018. Other recent recalls include the GE Optima XR220amx Mobile X-Ray System recall dated June 5, 2026, and the GE Healthcare medical imaging device recall dated May 1, 2026.
How to tell if you have this one
Check for SIGNA Architect MRI systems with gradient coils that have the GTINs listed: 00840682147095, 00840682122702, 00195278023643, or 00840682123440.
Brand
GE Medical Systems
Product
SIGNA Architect
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of China.
Verify if your SIGNA Architect MRI system has one of the listed GTINs: 00840682147095, 00840682122702, 00195278023643, or 00840682123440.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2130-2025 (May 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2130-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.