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Na 5265300-20

by GE Medical Systems, L.L.C. United States GUDID

Product code LNH

Regulatory status

as of 24 Oct 2026

Recall ongoing. 16 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682102728 UDI-DIDate1 Aug 2016ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

27 recalls · 16 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2306-2025 FDA Class II initiated 20 Jun 2025
    • Ongoing Z-2301-2025 FDA Class II initiated 20 Jun 2025
    • Ongoing Z-2302-2025 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-0517-2025 FDA Class II initiated 28 Oct 2024

    Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

  • 4 recalls, same reason

    • Ongoing Z-2464-2024 FDA Class II initiated 14 Jun 2024
    • Ongoing Z-2468-2024 FDA Class II initiated 14 Jun 2024
    • Ongoing Z-2467-2024 FDA Class II initiated 14 Jun 2024
    • Ongoing Z-2465-2024 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.

  • 4 recalls, same reason

    • Ongoing Z-0593-2022 FDA Class II initiated 23 Dec 2021
    • Ongoing Z-0602-2022 FDA Class II initiated 23 Dec 2021
    • Ongoing Z-0594-2022 FDA Class II initiated 23 Dec 2021
    • Ongoing Z-0601-2022 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.

  • 4 recalls, same reason

    • Ongoing Z-2055-2021 FDA Class II initiated 4 Jun 2021
    • Ongoing Z-2064-2021 FDA Class II initiated 4 Jun 2021
    • Ongoing Z-2063-2021 FDA Class II initiated 4 Jun 2021
    • Ongoing Z-2056-2021 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.

  • 3 recalls, same reason

    • Terminated Z-0135-2022 FDA Class II initiated 26 Aug 2021
    • Terminated Z-0136-2022 FDA Class II initiated 26 Aug 2021
    • Terminated Z-0140-2022 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-3279-2018 FDA Class II initiated 6 Jun 2018

    GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.

  • 4 recalls, same reason

    • Terminated Z-3025-2017 FDA Class II initiated 11 May 2017
    • Terminated Z-3023-2017 FDA Class II initiated 11 May 2017
    • Terminated Z-3022-2017 FDA Class II initiated 11 May 2017
    • Terminated Z-3024-2017 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-1188-2017 FDA Class II initiated 20 Jan 2017

    Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.

    • Terminated Z-2131-2016 FDA Class II initiated 8 Jun 2016

    GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used. No injury has been reported to GE as a result of this issue.

    • Terminated Z-0201-2019 FDA Class II initiated 7 Dec 2015

    GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue. UPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Full-body MRI system, superconducting magnet
Model / Reference
5265300-20
Primary DI / UDI-DI
00840682102728
510(k) Number
FDA Product Code
LNH
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class II
Regulation Number
892.1000
Commercial Distribution
In Commercial Distribution

Related devices

Category: Full-body MRI system, superconducting magnet

Cleared under the same submission (K142085)

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

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • FDA UDI a5205581-fc48-4c09-8a14-723901524298 33 fields · synced 23 Oct 2026