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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 Systems Recalled for Elevated Acoustic Noise Risk

Agency Publication Date: November 22, 2024
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Summary

GE Medical Systems, LLC has recalled several models of Magnetic Resonance (MR) imaging systems, including the Discovery MR750w 3.0T, SIGNA Architect, and SIGNA PET/MR. Approximately 66 units are affected by this recall because the gradient coils can produce elevated levels of acoustic noise during scanning under specific conditions. While no incidents or injuries have been reported, the excessive noise can cause patient discomfort or potential hearing issues. Facilities using these systems are being notified to take corrective actions.

Risk

The defect in the gradient coils causes the imaging system to generate sound levels that are louder than intended. This increased acoustic noise poses a potential risk of auditory discomfort or hearing impairment for patients during their MRI scans.

What You Should Do

  1. This recall affects GE Medical Systems MR imaging systems including Discovery MR750w 3.0T, SIGNA Architect, SIGNA Architect AIR, SIGNA PET/MR, and DISCOVERY PET/MR.
  2. Identify if your system is affected by checking the System ID or Unique Device Identifier (UDI) located on the equipment labels or facility records. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact GE Medical Systems or your authorized medical equipment distributor to arrange for a formal correction or inspection of the gradient coils.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices/medical-device-recalls 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: Discovery MR750w 3.0T, whole body magnetic resonance scanner
Model / REF:
Discovery MR750w 3.0T
Serial Numbers:
760724DVMR1
214820TS750WMR
281333MR2
82427240081
82427120136
82427200092
82427250061
EM0232
UDI:
(01)00840682103817(11)181200(21)PG75W1800047SC

System ID used as unit identifier.

Product: SIGNA Architect, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Architect
Serial Numbers (53):
303467MR2
1000005000
217528MR4
781SSHMR3
301295AMR2
GON90303794
215955HON3T
806UMCHWMR3T
703573ARC7
757953SPMR
905684MR3T
82427160355
82427100482
82427140330
82427040333
82427200209
82427050061
82427080138
82427150128
82427200219
82427080142
82427230234
82427100499
82427160405
82427160407
82427160390
82427160408
82427160402
82427120372
82427120357
82427120351
82427150130
82427030222
82427030218
83027009451123
MR00169
MR00168
MR00185
850270540
850270791
LV4001MR03
MRUA2408
P00434MR01
RF3138MR01
RU1838MR04
RF3580MR01
SA1058MR05
FEG88320
DE492A99
NEV439249
UDI:
(01)00840682147095(11)240100(21)PG75M2400278SC
(01)00840682147095(11)220800(21)PG75M2300225SC
(01)00840682147095(11)220600(21)PG75M2200130SC
(01)00840682147095(11)230600(21)PG75M2300245SC
(01)00840682147095(11)230800(21)PG75M2300255SC
(01)00840682122702(11)220100(21)PG75A2300133SC
(01)00840682147095(11)231000(21)PG75M2300263SC
(01)00840682147095(11)220800(21)PG75M2200153SC
(01)00840682147095(11)230400(21)PG75M2300232SC
(01)00840682147095(11)231000(21)PG75M2300266SC
(01)00840682147095(11)230600(21)PG75M2300247SC
(01)00840682147095(11)230700(21)PG75M2300253SC
(01)00840682147095(11)240100(21)PG75M2400276SC
(01)00195278283481(11)231113(21)CNARC2300071TJ
(01)00840682147095(11)230600(21)PG75M2300248SC
(01)00840682147095(11)240200(21)ANTAT2400005TJ
(01)00840682147095(11)240200(21)ANTAT2400004TJ
(01)00840682147095(11)240100(21)ANTAT2400001TJ
(01)00840682122702(11)180223(21)PG75A1800019MR
(01)00840682147095(11)230600(21)PG75M2300246SC
(01)00840682147095(11)221100(21)PG75M2200180SC
(01)00840682147095(11)230800(21)PG75M2300256SC
(01)00840682147095(11)230300(21)PG75M2300227SC

System ID used as unit identifier.

Product: SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
Model / REF:
SIGNA Architect AIR
Serial Numbers:
82427110161
82427090471
82427120353
82427140303
82427200210
82427090487
82427010214
82427070331
82427090477
82427160409
82427040320
82427090470
82427030219
82427090488
82427090469
82427200214
82427030223
82427060120
82427130176
82427100480
82427100491
82427250136
82427250132
82427110160
82427100496
82427100504
82427160403
82427030207
82427120364
82427120360
82427200224
82427200207
82427140310
82427140317
82427140308
82427190195
UDI:
(01)00195278283481(11)231214(21)CNARC2300080TJ
(01)00195278283481(11)230519(21)CNARC2300027TJ
(01)00195278283481(11)231116(21)CNARC2300072TJ
(01)00195278283481(11)230830(21)CNARC2300051TJ
(01)00195278283481(11)230515(21)CNARC2300026TJ
(01)00195278283481(11)230809(21)CNARC2300046TJ
(01)00195278283481(11)230816(21)CNARC2300048TJ
(01)00195278283481(11)230719(21)CNARC2300040TJ
(01)00195278283481(11)230904(21)CNARC2300052TJ
(01)00195278283481(11)231102(21)CNARC2300068TJ
(01)00195278283481(11)230722(21)CNARC2300041TJ
(01)00195278283481(11)231120(21)CNARC2300073TJ
(01)00195278283481(11)231009(21)CNARC2300060TJ
(01)00195278283481(11)240104(21)CNARC2400002TJ
(01)00195278283481(11)231207(21)CNARC2300078TJ
(01)00195278283481(11)230918(21)CNARC2300056TJ
(01)00195278283481(11)240131(21)CNARC2400008TJ
(01)00195278283481(11)240113(21)CNARC2400005TJ
(01)00195278283481(11)231109(21)CNARC2300070TJ
(01)00195278283481(11)230920(21)CNARC2300057TJ
(01)00195278283481(11)231010(21)CNARC2300061TJ
(01)00195278283481(11)230729(21)CNARC2300043TJ
(01)00195278283481(11)240116(21)CNARC2400006TJ
(01)00195278283481(11)240110(21)CNARC2400004TJ
(01)00195278283481(11)231026(21)CNARC2300066TJ
(01)00195278283481(11)231204(21)CNARC2300077TJ
(01)00195278283481(11)230508(21)CNARC2300024TJ
(01)00195278283481(11)231221(21)CNARC2300081TJ
(01)00195278283481(11)240102(21)CNARC2400001TJ
(01)00195278283481(11)231019(21)CNARC2300064TJ
(01)00195278283481(11)240127(21)CNARC2400007TJ
(01)00195278283481(11)231030(21)CNARC2300067TJ
(01)00195278283481(11)231016(21)CNARC2300063TJ
(01)00195278283481(11)230818(21)CNARC2300049TJ
(01)00195278283481(11)230911(21)CNARC2300054TJ
(01)00195278283481(11)230913(21)CNARC2300055TJ

System ID used as unit identifier.

Product: SIGNA PET/MR and DISCOVERY PET/MR Tomographic Imagers
Variants: SIGNA PET/MR, DISCOVERY PET/MR
Model / REF:
SIGNA PET/MR
DISCOVERY PET/MR
Serial Numbers:
82427070262
EX0133

System ID used as unit identifier.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95735
Status: Active
Manufacturer: GE Medical Systems, LLC
Sold By: GE Medical Systems; Authorized medical equipment distributors
Manufactured In: United States
Units Affected: 4 products (8 units; 53 units; 3 units; 2 units)
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.

Find an Attorney

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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.