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Na G3341AB

by GE Medical Systems, L.L.C.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 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 Number00840682115889 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

10 recalls · 5 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2463-2024 FDA Class II initiated 14 Jun 2024
    • Ongoing Z-2471-2024 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-0860-2022 FDA Class II initiated 18 Feb 2022

    There is potential for the images to be flipped left to right.

    • Ongoing Z-0603-2022 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-2065-2021 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-0141-2022 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-0877-2020 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.

    • Terminated Z-0693-2019 FDA Class II initiated 15 Nov 2018

    Possible incorrect software version loaded.

    • Terminated Z-3028-2017 FDA Class II initiated 11 May 2017

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

    • Terminated Z-2266-2013 FDA Class II initiated 9 Apr 2013

    GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit

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
G3341AB
Primary DI / UDI-DI
00840682115889
510(k) Number
FDA Product Code
LNH, MOS, LNI
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class II
Regulation Number
892.1000
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K121676)

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