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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE MR Imaging Systems Recalled for Potential Caster Lock Failure

Agency Publication Date: August 13, 2025
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Summary

GE Medical Systems, LLC (GE HealthCare) has recalled approximately 4,699 MR Imaging Systems because the patient table caster locks may not have been properly inspected during routine maintenance. The recall affects a wide range of products including SIGNA, Discovery, and Optima models that received planned maintenance after March 1, 2023. If the locks were not checked and fail to function, the patient table could move unexpectedly during use. No incidents or injuries have been reported to date, but GE HealthCare is performing this voluntary recall to ensure all locks are functional.

Risk

A failure of the patient table caster locks can result in unintended movement of the table during patient transfers or while a procedure is underway. This movement poses a risk of physical injury to patients or clinical staff.

What You Should Do

  1. This recall affects various GE MR Imaging Systems, including SIGNA Artist, Voyager, Architect, Premier, Hero, PET/MR, and Discovery MR450/MR750 series, as well as Optima MR450w systems.
  2. Identify if your device is affected by checking the system model name and verifying if the unit has received planned maintenance from GE HealthCare since March 1, 2023.
  3. Check the GTIN and Recall Number associated with your specific system. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  5. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Artist
GTIN:
00840682123129
00840682146104
00195278117021
00840682123457
00195278126443
00195278210036
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2299-2025; Quantity: 760 units

Product: GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Voyager
GTIN:
00840682108607
00195278124609
00195278248923
00840682118118
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2300-2025; Quantity: 280 units

Product: GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Model / REF:
Discovery MR450 1.5T
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2301-2025; Quantity: 19 units

Product: GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Model / REF:
Optima MR450w 1.5T
GTIN:
00195278023643
00195278117021
00195278126443
00195278210036
00195278229519
00840682115971
00840682118118
00840682118132
00840682123129
00840682123457
00840682146104
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2302-2025; Quantity: 1372 units

Product: GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Architect
GTIN:
00195278023643
00195278117021
00840682102728
00840682103817
00840682118118
00840682122702
00840682123129
00840682123440
00840682146197
00840682147095
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2303-2025; Quantity: 758 units

Product: GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Premier
GTIN:
00840682146999
00195278010797
00840682135269
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2304-2025; Quantity: 214 units

Product: GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA UHP
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2305-2025; Quantity: 3 units

Product: GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
Model / REF:
Discovery MR750 3.0T
GTIN:
00195278229519
00840682115872
00840682115971
00840682118187
00840682123129
00840682146999
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2306-2025; Quantity: 330 units

Product: GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
Model / REF:
Discovery MR750w 3.0T
GTIN:
00195278023643
00840682102704
00840682102728
00840682103787
00840682103817
00840682123440
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2307-2025; Quantity: 519 units

Product: GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Hero
GTIN:
00195278472083
00195278486813
001952784868131
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2308-2025; Quantity: 56 units

Product: GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
Model / REF:
SIGNA PET/MR
GTIN:
00195278648877
00840682105378
00840682123440
00840682135283
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2309-2025; Quantity: 97 units

Product: GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Artist Evo
GTIN:
00195278481382
00840682118118
00840682123129
00840682147095
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2310-2025; Quantity: 138 units

Product: GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Voyager AIR
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2311-2025; Quantity: 0

Product: GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Architect AIR
GTIN:
00840682102728
00840682103787
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2312-2025; Quantity: 151 units

Product: GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Premier XT
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2313-2025; Quantity: 2 units

Product: GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Premier Elite
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2314-2025; Quantity: 0

Product: GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Premier MAX
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2315-2025; Quantity: 0

Product: GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Hero XT
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2316-2025

Product: GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Hero Elite
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2317-2025; Quantity: 0

Product: GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Hero MAX
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2318-2025; Quantity: 0

Product: GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA PET/MR AIR
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2319-2025; Quantity: 0

Product: GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA PET/MR AIR Plus
Date Ranges: Maintained since March 1, 2023

Recall #: Z-2320-2025; Quantity: 0

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97187
Status: Active
Manufacturer: GE Medical Systems, LLC
Sold By: GE HealthCare authorized distributors; Direct medical sales
Manufactured In: United States
Units Affected: 21 products (760 units; 280 units; 19 units; 1372 units; 758 units; 214 units; 3 units; 330 units; 519 units; 56 units; 97 units; 138 units; 0; 151 units; 2 units; 0; 0; 0; 0; 0; 0)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.