Z-1767-2026Class II

SIGNA Premier systems

Name: Z-1767-2026 SIGNA Premier systems
Creator: GE Healthcare LLC
Published: 2026-02-27
License: https://open.fda.gov/license/

GE Healthcare / initiated 2026-02-27 / Open, Classified / root cause: manufacturing process

FDA source

GE Healthcare LLC began a recall of SIGNA Premier systems on 2026-02-27. FDA classified it as Class II and gives the reason as "Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1767-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-27
Posted: 2026-04-02
Recalling firm: GE Healthcare
Product: SIGNA Premier systems
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 2/27/2026, correction notices were mailed to Director of Clinical/Radiology Risk Manager/Hospital Administrators informing them to take the following actions: 1) Ensure all potential servicing personnel in your facility are made aware of this safety notification and the recommended actions. 2) If the device requires service at the rear of the magnet, ensure that all servicing personnel are aware of this potential issue. 3) If servicing personnel have accessed the rear of the magnet with covers removed and identified that ferrous fittings are installed, do NOT attempt to remove or disconnect them. Call your GE HealthCare representative immediately. To help identify the parts: -The incorrect fittings (ferrous) are steel/silver in color -The correct fittings (non-ferrous) are brass/gold in color 4) Complete and return the acknowledgement form electronically via (https://gehealthcare-svc.my.site.com/publicForm/s/?formId=aGjUr000002kiJR) or print, fill out manually, scan and email to [email protected] If you have any questions or concerns regarding this notification, please contact the firm's HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 41
Distribution: Worldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of
Product codes and lots: UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T, 513584MR5, 513636EASTMR, 513636T1MR, 605333MRPRM, 832522CRMR1, 703858PRE2, 804675VA3T, 082427110162, 082427220143, 082427020147, 082427200242, 082427160461, 082427250139, 082427140382, M4216469, 353745MR01, GON5655515, KRMR56474971, KRMR56203791, KRMR55433661, KRMR56344161, KRMR55774051, KRMR55914661, NOMRI26833321, 15974045, GON1882380, ESMRI27056983, ESMRI26960129, A203MR06, 690120MR01, 11524261, VNMRI26792525, VNMRI26592248, VNMRI26809677

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1767-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1767-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-08	2026-04-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)