GE Medical Systems, LLC recall records

124 reported ongoing

124 records in this archive. Latest source date Jun 5, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System

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...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
FDA device enforcement

SIGNA Architect

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 est...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the country of China.

Official source for SIGNA Architect
FDA device enforcement

SIGNA Architect AIR

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 est...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the country of China.

Official source for SIGNA Architect AIR
FDA device enforcement

Discovery MR750w 3.0T

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 est...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the country of China.

Official source for Discovery MR750w 3.0T
FDA device enforcement

SIGNA PET/MR

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 est...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the country of China.

Official source for SIGNA PET/MR
FDA device enforcement

OEC 3D

OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.

Class IIReported ongoing

Distribution: US and OUS

Official source for OEC 3D
FDA device enforcement

Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number H...

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114V...
FDA device enforcement

Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for Ch...

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution.

Official source for Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFS...
FDA device enforcement

GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the g...

Class IIReported ongoing

Distribution: Worldwide distribution.

Official source for GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

Reasons in these listed records

  • 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 ...
  • 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 Internat...
  • OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
  • The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

These examples come from this result page and are not a ranking of every recall reason.

Checking GE Medical Systems, LLC

Is there a recall on ge medical systems, llc right now?

This archive contains 124 records, including 124 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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