Z-1430-2022Class II

SIGNA Premier magnetic resonance scanner, model 5748519

Name: Z-1430-2022 SIGNA Premier magnetic resonance scanner, model 5748519
Creator: GE Healthcare, LLC
Published: 2022-06-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-06-24 / Open, Classified / root cause: design

FDA source

GE Healthcare, LLC began a recall of SIGNA Premier magnetic resonance scanner, model 5748519 on 2022-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1430-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-07-21
Recalling firm: GE Healthcare
Product: SIGNA Premier magnetic resonance scanner, model 5748519.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 6/24/2022 via traceable means on 6/24/2022. The letter explained the safety issue, affected product details, and actions to be taken by the customer/user. The consignee is informed they can continue to use the device but ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. The firm provided an Operator Manual addendum for the impacted devices to require the use of hearing protection with a Noise Reduction Rating (NRR) of 33dB. To assist with the transition, the firm provided an initial quantity of 200 pairs of disposable ear protection with an NRR of 33dB. A response form was enclosed for completion and return no later than 30 days from receipt to confirm receipt and understanding of the notice.
Quantity in commerce: 52
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, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
Product codes and lots: SIGNA Premier GTINs: 00840682135269 and 00195278010797

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1430-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1430-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code LNH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)