Ge Medical Systems, LLC
Ge Medical Systems, LLC holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2026, with 168 FDA device recalls on record.
Top product codes for Ge Medical Systems, LLC
FDA recalls by Ge Medical Systems, LLC
10 most recent of 168- Z-2726-2026 — Optima XR200amx, Mobile Digital-Ready Radiographic System
- Z-2727-2026 — Optima XR220amx, Mobile Digital-Ready Radiographic System
- Z-2728-2026 — Optima XR240amx, Mobile Digital Radiographic System
- Z-2477-2026 — Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- Z-2475-2026 — Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Z-2476-2026 — Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
- Z-2314-2026 — Allia IGS 3 Pulse angiographic X-ray system
- Z-2317-2026 — Allia IGS Pulse angiographic X-ray system
- Z-2318-2026 — Allia Moveo angiographic X-ray system
- Z-2315-2026 — Allia IGS 5 Pulse angiographic X-ray system
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Medical Systems, LLC
1–100 of 105- K253560 — Enhanced Boundary for PCCT
- K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm
- K253520 — Photonova Spectra, Photonova Spectra Select
- K253780 — SIGNA Bolt
- K253779 — SIGNA Sprint Select
- K252379 — AIR Recon DL
- K251399 — SIGNA Sprint
- K250941 — Revolution Vibe
- K243667 — Sonic DL
- K250379 — SIGNA Prime Elite
- K241242 — SIGNA MAGNUS
- K233750 — ECG-less Cardiac
- K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
- K230082 — Auto Segmentation
- K223514 — Spectral Bone Marrow
- K213999 — Deep Learning Image Reconstruction
- K213709 — SIGNA PET/MR
- K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more
- K211161 — Critical Care Suite with Endotracheal Tube Positing AI algorithm
- K211846 — Discovery MI Gen2
- K211118 — SIGNA 7.0T
- K210982 — AMX Navigate
- K203617 — MaxFOV 2
- K201745 — Deep Learning Image Reconstruction for Gemstone Spectral Imaging
- K201615 — SIGNA 7.0T
- K183182 — Critical Care Suite
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- K183202 — Deep Learning Image Reconstruction
- K183161 — SnapShot Freeze 2
- K183231 — SIGNA Premier
- K182234 — Optima XR240amx
- K180318 — PET Digital Gating
- K173602 — Optima XR240amx, AutoGrid
- K171128 — SIGNA Premier
- K162722 — HyperSense
- K163331 — Discovery MR750 3.0T +4 more
- K163619 — SIGNA PET/MR
- K163213 — Revolution CT
- K162403 — HyperBand
- K162990 — Optima XR240amx
- K161397 — MAGiC
- K161574 — Discovery MI
- K160618 — Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
- K151372 — Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
- K143368 — GenIQ
- K150193 — Customer Remote Console (CRC)
- K142361 — Discovery MR750 3.0T
- K142098 — SIGNA PET/MR
- K142085 — DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T
- K142383 — Optima XR200amx, Optima XR220amx
- K141074 — CORTEX ID SUITE
- K141477 — DISCOVERY IQ
- K133705 — REVOLUTION CT
- K133640 — ASIR-V
- K133657 — DISCOVERY PET/CT 710
- K132410 — DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
- K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
- K131576 — OPTIMA CT660
- K130115 — DISCOVERY MR750W 3.0T
- K121762 — CARDIAC VX
- K113394 — MAVRIC SL
- K123068 — OPTIMA MR 430S
- K121676 — 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT
- K120833 — DISCOVERY CT750 HD
- K113408 — Q. FREEZE (MOTION VUE2)
- K113490 — OPTIMA MR450W
- K103448 — BRIVO XR385
- K110227 — OPTIMA CT660
- K111304 — OPTIMA XR120
- K103476 — BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX
- K093581 — DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
- K110610 — 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
- K103480 — THORACIC VCAR
- K103238 — 1.5T OPTIMA MR430S
- K102615 — WIRELESS DR IMAGING OPTION-WDR1
- K102155 — MR RADIATION ONCOLOGY OPTIONS
- K092925 — 3D ASL
- K083421 — MR-TOUCH OPTION
- K091536 — OPTIMA MR450W
- K083147 — DISCOVERY MR450
- K082960 — GE XTREME INJECTOR OPTION
- K082761 — GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
- K082816 — GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
- K081985 — AW SERVER
- K081916 — GE SIGNA MR ONCOLOGY PACKAGE
- K081496 — OPTIMA PET/CT 560
- K081028 — SIGNA 3.0T MR750 SYSTEM
- K073167 — BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER
- K072998 — IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
- K061817 — LIGHTSPEED 7.1 CT SCANNER SYSTEM
- K061028 — PRECISION THUNIS 800+
- K061163 — INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
- K060052 — GE LIGHTSPEED XTRA CT SCANNER SYSTEM
- K060259 — DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
- K052978 — GE 1.5T SIGNA HDE MR SYSTEM
- K052293 — GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
- K052157 — INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
- K050489 — INNOVA 2100
- K042602 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING
- K041921 — GE SIGNA PROFILE 6 INCH GP COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.