Skip to content

NA SIGNA Premier

by GE Medical Systems, L.L.C.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682135269 UDI-DI Date11 Dec 2017ListedStatusListed GUDID: in commercial distribution

Recalls

8 recalls · 6 ongoing · FDA

    • Ongoing Z-1767-2026 FDA Class II initiated 27 Feb 2026

    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.

    • Ongoing Z-2304-2025 FDA Class II initiated 20 Jun 2025

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    • Ongoing Z-2462-2024 FDA Class II initiated 14 Jun 2024

    GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

    • Ongoing Z-1430-2022 FDA Class II initiated 24 Jun 2022

    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.

    • Ongoing Z-0590-2022 FDA Class II initiated 23 Dec 2021

    The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

    • Ongoing Z-2052-2021 FDA Class II initiated 4 Jun 2021

    GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.

    • Terminated Z-0132-2022 FDA Class II initiated 26 Aug 2021

    Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

    • Terminated Z-0874-2020 FDA Class II initiated 23 Dec 2019

    It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Full-body MRI system, superconducting magnet
Model / Reference
SIGNA Premier
Primary DI / UDI-DI
00840682135269
510(k) Number
FDA Product Code
MOS, LNI, LNH
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class II
Regulation Number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full-body MRI system, superconducting magnet

Other devices from GE Medical Systems, L.L.C.

See all devices from GE Medical Systems, L.L.C. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No