Lower riskMedical device recall · FDA · Published June 24, 2022
GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise
GE Healthcare recalls SIGNA Premier MRI scanners (model 5748519) due to rare risk of hearing loss from elevated acoustic noise during scans. Affected units have specific GTINs.
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
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Contact the company
📍Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
“GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60423-ge-healthcare-signa-premier-mri-scanner-recall-risk-of-hearing. Based on FDA recall #Z-1430-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1430-2022%22&limit=1).
The FDA announced on June 24, 2022, that GE Healthcare LLC is recalling the SIGNA Premier magnetic resonance scanner, model 5748519. The hazard involves elevated acoustic noise during scanning that could potentially lead to hearing loss.
How to tell if you have it
Brand: GE Healthcare
Product: SIGNA Premier magnetic resonance scanner
Model: 5748519
GTINs: 00840682135269, 00195278010797
Units affected: 52
The hazard
Under rare conditions, the SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since October 4, 2017. Other recent recalls include the GE Healthcare SIGNA Premier MRI Scanners recall dated February 27, 2026, and the GE Centricity Universal Viewer 6.0/7.0/8.0 recall dated July 15, 2022. Similar product recalls include the Philips Brilliance CT 64 Medical Scanner recall on August 7, 2026, and the Philips Avalon Fetal Monitor recall on May 26, 2026.
How to tell if you have this one
Check for model number 5748519 on the scanner. Affected units have GTINs: 00840682135269 and 00195278010797.
Brand
GE Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model number 5748519 on the scanner.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Michigan, Minnesota, New York, Wisconsin.
Recall timeline
FDA published this recall 33 days 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-1430-2022 (June 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1430-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.