Discovery MR750 3.0T Split Head Coil

• 5 recalls, same reason

  • Ongoing Z-2299-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2302-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2306-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2301-2025 FDA Class II ·initiated 20 Jun 2025
  • Ongoing Z-2303-2025 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-2130-2025 FDA Class II ·initiated 23 May 2025

  GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

• 3 recalls, same reason

  • Ongoing Z-0518-2025 FDA Class II ·initiated 28 Oct 2024
  • Ongoing Z-0517-2025 FDA Class II ·initiated 28 Oct 2024
  • Ongoing Z-0519-2025 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.

• 6 recalls, same reason

  • Ongoing Z-2459-2024 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
  • Ongoing Z-2469-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2468-2024 FDA Class II ·initiated 14 Jun 2024
  • Ongoing Z-2464-2024 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.

• 5 recalls, same reason

  • Ongoing Z-0600-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0593-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0594-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0591-2022 FDA Class II ·initiated 23 Dec 2021
  • Ongoing Z-0602-2022 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.

• 6 recalls, same reason

  • Ongoing Z-2056-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2055-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2064-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2053-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2063-2021 FDA Class II ·initiated 4 Jun 2021
  • Ongoing Z-2061-2021 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.

• 5 recalls, same reason

  • Terminated Z-0133-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0140-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0139-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0136-2022 FDA Class II ·initiated 26 Aug 2021
  • Terminated Z-0135-2022 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.

• 4 recalls, same reason

  • Terminated Z-0129-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0130-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0128-2021 FDA Class II ·initiated 8 Sep 2020
  • Terminated Z-0127-2021 FDA Class II ·initiated 8 Sep 2020

  Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

• • Terminated Z-0875-2020 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.

• 3 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

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

• • 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.

• • Terminated Z-1533-2014 FDA Class II ·initiated 23 Apr 2014

  GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle release block mechanism malfunctions or becomes misaligned. This could make the safe removal of the patient from the system difficult.

• • Terminated Z-1480-2014 FDA Class II ·initiated 2 Apr 2014

  Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the Rear Endbell enclosure to overheat, generate smoke in the scan room, and cause some localize

• • Terminated Z-2291-2013 FDA Class II ·initiated 13 Aug 2013

  GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed

• • 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

• • Terminated Z-1207-2013 FDA Class II ·initiated 8 Jun 2012

  GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers

• 2 recalls, same reason

  • Terminated Z-3123-2011 FDA Unclassified (pre-2012) ·initiated 29 Jul 2011
  • Terminated Z-3122-2011 FDA Unclassified (pre-2012) ·initiated 29 Jul 2011

  GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1) Inline post-processed (i.e. automated post-processing) image locations are not correctly annotated under some conditions. 2) Reference images displayed in Functool FiberTrak do not match with

• • Terminated Z-0935-2013 FDA Class II ·initiated 10 May 2011

  An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

• • Terminated Z-1375-2011 FDA Unclassified (pre-2012) ·initiated 18 Nov 2010

  GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR systems that may impact service or maintenance personnels safety. The gradient cooling manifolds used on the affected systems may contain electrically conductive hoses, which become live when the g

• • Terminated Z-0592-2010 FDA Unclassified (pre-2012) ·initiated 6 Oct 2009

  GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p

Trade Name

Discovery MR750 - 3.0T Split Head Coil EUDAMED

Na GUDID

Generic Name

Full-body MRI system, superconducting magnet

Device Name

1.5T and 3.0T Split Head Coil

Model / Reference

5182872 EUDAMED

Discovery MR750 - 3.0T Split Head Coil GUDID

Primary DI / UDI-DI

00840682104944

Basic UDI-DI

8406821BUG00371HJ

510(k) Number

K081028 ↗

FDA Product Code

LNH

EMDN Code

Z1105018002 Magnetic resonance (mr) radiofrequency volumetric coils

GMDN Term

Full-body MRI system, superconducting magnet

Device Class

Class IIa EUDAMED

Class II GUDID

Regulation Number

892.1000

Market of Registration

France

Commercial Distribution

In Commercial Distribution

MRI Safety

MR Safe

EUDAMED SRN

US-MF-000001632

Authorised representative

GE Medical Systems SCS FR-AR-000000344

Category: MRI system coil, radio-frequency

• Discovery MI Gen2

  Class IIb

  CE/MDR

• CortexID Suite

  Class IIa

  CE/MDD

• not applicable PRISTINA 2.10

  Class II

  GUDID on market

• SenoIris 1

  Class II

  GUDID on market

• Thoracic Vcar

  Class II

  FDA 510(k) K103480 Active Cleared 7 Mar 2011

• MaxFOV 2

  Class II

  FDA 510(k) K203617 Active Cleared 2 Mar 2021

See all devices from GE Medical Systems, LLC →

• What is the primary purpose of the Discovery MR750 - 3.0T Split Head Coil in MRI imaging?

  The Discovery MR750 - 3.0T Split Head Coil is designed to enhance MRI imaging of the brain and surrounding structures by improving signal reception and spatial resolution when used with 3.0 Tesla MRI systems. Its split design helps optimize coverage and clarity for detailed diagnostic evaluations.

• Is the Discovery MR750 - 3.0T Split Head Coil reusable or single-use, and what does this mean for clinical workflows?

  The coil is explicitly intended for single-use only, meaning it cannot be reprocessed or reused after a single procedure. Clinicians should account for this in workflow planning, ensuring proper disposal after use to maintain safety and compliance with manufacturer guidelines.

• How should the Discovery MR750 - 3.0T Split Head Coil be stored, and are there any special handling requirements?

  While the data does not specify exact storage conditions, the manufacturer’s guidelines (referenced in the description) must be followed to preserve performance and safety. Since it is not sterile and designed for single-use, storage should protect it from contamination and physical damage until use.

• What regulatory pathways does the Discovery MR750 - 3.0T Split Head Coil follow, and how does this affect its use?

  The coil is authorized under FDA 510K and MDR (Medical Device Regulation) pathways, indicating compliance with U.S. and EU regulatory standards. This means it meets predefined safety and performance criteria for Class IIa devices, ensuring its suitability for clinical use in authorized markets.

• Does the Discovery MR750 - 3.0T Split Head Coil come in multiple sizes or models, or is it a single configuration?

  The provided data does not list multiple sizes or models for this specific coil. It is identified as the Discovery MR750 - 3.0T Split Head Coil, suggesting a standardized design optimized for 3.0T MRI systems, though compatibility with other systems should be verified per manufacturer instructions.