What does GE Medical Systems (China) Co., Ltd. manufacture?

Registered with the FDA for 57 device types.

Is GE Medical Systems (China) Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

GE Medical Systems (China) Co., Ltd.

Manufacturer and brand owner in Wuxi, Jiangsu, China. 57 device types, 18 products catalogued, 13 clearances.

Registry build 21.09.26

GE Medical Systems (China) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Oximeter, Ear and 55 other device types. 18 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 1995.

57device types registered with the FDA

18products catalogued under its own name

13510(k) clearances

27recalls

Registration

FDA registration record for GE Medical Systems (China) Co., Ltd.
Registered name	GE MEDICAL SYSTEMS (CHINA) CO., LTD.
Status	Registered
Registration expires	2026
Registration number	9710602
FEI number	3003513129
DUNS	654658731
Establishment type	Contract manufacturer, Specification developer, Manufacturer

Chinese Registration

Chinese company register details for GE Medical Systems (China) Co., Ltd.
Chinese legal name	通用电气医疗系统（中国）有限公司
Unified social credit code	913202146079203728
Source	NMPA UDI database

Location

Address of GE Medical Systems (China) Co., Ltd.
City	Wuxi
Province	Jiangsu
Address	NO. 19 CHANGJIANG ROAD
Postal code	214028
Country	China

Group

GE Medical Systems (China) Co., Ltd. is one of 5 plants registered under GE HealthCare Technologies Inc..

Other plants under GE HealthCare Technologies Inc.
Plant	City	Device types
GE Hangwei Medical Systems Co., Ltd.	Beijing	22
GE Healthcare (China) Co., Ltd.	Beijing	22
GE Healthcare (Tianjin) Company Limited	Tianjin	5
GE Healthcare (China) Co., Ltd. – Tianjin	Tianjin	3

What It Makes

Device types GE Medical Systems (China) Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Absorber, Carbon-Dioxide	Class 1	Multi Absorber Canister, ABS Reusable Absorbent Canister, CBS Reusable Absorbent Canister, Multi-Absorber canister reusable, Absorber canister assembly, Reusable CO2 Absorber Canister and 3 more	2002	6
Alarm, Blood-Pressure	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	7
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	29
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	5
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	6
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	6
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 9 more	2022	5
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	6
Analyzer, Gas, Oxygen, Gaseous-Phase	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	8
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	5
Automated Breast Ultrasound	Class 3	Invenia ABUS Premium, Invenia ABUS Scan Station, Invenia ABUS Workstation, Invenia ABUS, ABUS Single-Use Stabilization Membrane – non Sterile, Invenia ABUS Review Software and 2 more	2013	1
Automated Radiological Image Processing Software	Class 2	6S-D, C3-10-D, L4-20t-D, BE9CS-D, C1-6-D, RAB6-D and 74 more	2023	8
Bone Sonometer	Class 2	Achilles OsteoReportN, Achilles EXPII	2011	1
Burst Suppression Detection Software For Electroencephalograph	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 15 more	2008	3
Cable, Electrode	Class 2	Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables), ECG Trunk Cables and Leadwires, ECG Adapter Cable, Novii Cables (NOVII INTERFACE CABLE – GE FECG; NOVII INTERFACE CABLE – GE MECG; NOVII INTERFACE CABLE – GE UA), Novii Interface Cable – GE Mecg, MECG Cable and 17 more	2018	47
Cable, Transducer And Electrode, Patient, (Including Connector)	Class 2	MAC 7 Resting ECG Analysis System	2026	22
Catheter, Intravascular, Diagnostic	Class 2		2014	11
Catheter, Ultrasound, Intravascular	Class 2	9L-D, 6S-D, P6D, C1-6-D, 11L-D, 9T-RS and 20 more	2021	4
Cerebral Oximeter	Class 2	CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display	2023	2
Computer, Blood-Pressure	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	12
Computer, Diagnostic, Pre-Programmed, Single-Function	Class 2	CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00, PiCCO Injectate Sensor Cable (M1182448), PiCCO Continuous Cardiac Output Cable (M1154585), CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000 and 1 more	2014	5
Computer, Diagnostic, Programmable	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 17 more	2021	10
Computer, Oxygen-Uptake	Class 2	CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display	2023	3
Continuous Measurement Thermometer	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor, B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M and 12 more	2022	115
Detector And Alarm, Arrhythmia	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	10
Electrocardiograph	Class 2	MAC 7 – Resting ECG Analysis System, MAC 5 A4 Resting ECG Analysis System, MAC 5 Lite, MAC 5 A4, MAC 5 A5, MAC 5 A5 Resting ECG Analysis System and 5 more	2021	18
Electrode, Cutaneous	Class 2	GE Entropy Sensor (REFM1038681), GE Entropy Cable (REF M1050784)	2008	47
Full-Montage Standard Electroencephalograph	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	3
Gas-Machine, Anesthesia	Class 2	Carestation 650c, Carestation 650 A1, Carestation 650c A1, Carestation 620/650/650c, Carestation 620, Carestation 620 A1 and 6 more	2016	4
Incubator, Neonatal	Class 2	Giraffe Incubator Carestation CS1, Giraffe Incubator Carestation, Disposable Infant Skin Temperature Probe, Giraffe Panda Disposable Infant Skin Temperature Probe, Giraffe OmniBed Carestation CS1, Giraffe OmniBed Carestation	2016	2
Index-Generating Electroencephalograph Software	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	4
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Class 2	CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display	2023	7
Monitor, Breathing Frequency	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	8
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	9
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor	2024	17
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor, B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M and 24 more	2008	9
Monitor, St Segment With Alarm	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 15 more	2008	7
Non-Normalizing Quantitative Electroencephalograph Software	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 15 more	2008	3
Oximeter	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor, B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M and 17 more	2010	70
Oximeter, Ear	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor, B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M and 17 more	2010	4
Oximeter, Tissue Saturation	Class 2	CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display	2023	5
Probe, Thermodilution	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 10 more	2022	3
Recorder, Paper Chart	Class 1	B1X5-REC, Recorder	1995	9
Reduced- Montage Standard Electroencephalograph	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 15 more	2008	3
Spirometer, Monitoring (W/Wo Alarm)	Class 2	CARESCAPE Canvas D19, F2 Frame (F2-01), CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display	2023	5
Stimulator, Auditory, Evoked Response	Class 2	Datex-Ohmeda S/5 EEG Module, E-EEG Datex-Ohmeda S/5 EEG Headbox, AEP Ear Tips for Earphone Set (8001233), EEG Lead set 1 (898050), EEG Lead set 3 (898052), CARESCAPE Canvas D19 and 3 more	2008	4
Stimulator, Nerve, Peripheral, Electric	Class 2	B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M, B125P Patient Monitor, B155M Patient Monitor and 18 more	2008	5
System, Image Processing, Radiological	Class 2	Achilles OsteoReportN, Invenia ABUS Viewer	2013	16
System, Imaging, Pulsed Doppler, Ultrasonic	Class 2	9L-RS, E8C-RS, 6S-RS, Venue Go, L8-18i-RS, L4-12t-RS and 223 more	2007	22
System, Imaging, Pulsed Echo, Ultrasonic	Class 2	9L-RS, E8C-RS, 6S-RS, Venue Go, L8-18i-RS, L4-12t-RS and 221 more	2007	37
System, Measurement, Blood-Pressure, Non-Invasive	Class 2	Portrait™ VSM, Portrait VSM Vital Signs Monitor, B105P Patient Monitor, Monitor B155M, B125M Patient Monitor, Monitor B125M and 12 more	2022	98
System, Monitoring, Perinatal	Class 2	2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only	2010	6
Transducer, Ultrasonic, Diagnostic	Class 2	9L-RS, E8C-RS, 6S-RS, Venue Go, L8-18i-RS, L4-12t-RS and 224 more	2007	44
Transmitters And Receivers, Electrocardiograph, Telephone	Class 2	MAC 7 – Resting ECG Analysis System, MAC 5 A4 Resting ECG Analysis System, MAC 5 Lite, MAC 5 A4, MAC 5 A5, MAC 5 A5 Resting ECG Analysis System and 1 more	2021	6
Twister, Brace Setting	Class 1	12S-RS, M5Sc-RS, 9L-RS, E8C-RS, L4-20t-RS, ML6-15-RS and 13 more	2026	1
Ventilator, Continuous, Facility Use	Class 2	Carescape R860, R860, CARESCAPE R860 Ventilator	2015	8
Warmer, Infant Radiant	Class 2	Panda Warmer, Giraffe Warmer, Panda Freestanding Warmer, Giraffe Panda Disposable Infant Skin Temperature Probe, Disposable Infant Skin Temperature Probe, Panda Wall Mount Warmer and 3 more	2013	3

Own-Brand Listings

Devices catalogued by GE Medical Systems (China) Co., Ltd.
Product	Code	Catalogue numbers
Logiq	IYO	11
Vivid	IYO	10
Transducer, Ultrasonic, Diagnostic	ITX	8
Logiq	ITX	8
Versana	IYO	7
Vivid	ITX	7
Versana	IYN	7
System, Imaging, Pulsed Echo, Ultrasonic	IYO	7
Vivid	IYN	7
Versana	ITX	4
Logiq	IYN	3
Venue	IYN	2
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2
Achilles Expii	MUA	1
vivid iq	ITX	1
Venue	ITX	1
Cable, Electrode	IKD	1
Venue	IYO	1

Clearances

13 clearances name GE Medical Systems (China) Co., Ltd. as applicant. 127 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming GE Medical Systems (China) Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K171580	2017-11-01	MHX	Traditional	This company
K151063	2015-12-15	MHX	Special	This company
K142288	2014-12-03	DPS	Special	This company
K133576	2014-02-21	MHX	Special	This company
K130584	2013-06-26	MHX	Traditional	This company
K122253	2013-03-22	MHX	Special	This company
K123238	2013-02-25	MUA	Traditional	This company
K120598	2012-07-19	MHX	Traditional	This company
K103633	2011-05-11	MUA	Traditional	This company
K102256	2010-10-05	IYN	Traditional	This company
K102113	2010-08-12	IYN	Traditional	This company
K091374	2009-05-26	IYO	Traditional	This company
K091164	2009-05-05	IYN	Traditional	This company
K261668	2026-08-07	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K261835	2026-07-30	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K253277	2026-07-24	MHX	Traditional	GE Medical Systems Information Technologies, Inc.
K260398	2026-05-26	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K260673	2026-03-24	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K251670	2026-01-26	DPS	Traditional	GE Medical Systems Information Technologies, Inc.
K253370	2026-01-08	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K253366	2026-01-07	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K252328	2025-11-24	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K251963	2025-10-29	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K251985	2025-10-29	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K251322	2025-07-25	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K251169	2025-07-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K250543	2025-05-29	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K243620	2025-02-11	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K243628	2025-02-11	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K242168	2024-12-20	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K242005	2024-10-02	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K240053	2024-06-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K240206	2024-06-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K240111	2024-06-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K234106	2024-06-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K233810	2024-04-25	MWI	Traditional	GE Medical Systems Information Technologies, Inc.
K233692	2024-03-07	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K232381	2023-12-07	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K231989	2023-11-07	IYN	Traditional	Ge Medical Systems Ultrasound and Primary Care Diagnostic,
K231966	2023-11-07	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K232186	2023-11-03	IYN	Traditional	Ge Medical Systems Ultrasound and Primary Care Diagnostic,
K231965	2023-10-30	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K230346	2023-06-20	IYN	Traditional	Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC
K223531	2023-04-06	MHX	Traditional	GE Healthcare Finland OY
K213867	2023-03-28	BSZ	Traditional	Datex-Ohmeda, Inc.
K223832	2023-02-16	IYN	Traditional	Ge Medical System Ultrasound and Primary Care Diagnostics
K223407	2023-02-15	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K221321	2022-10-18	DPS	Traditional	GE Medical Systems Information Technologies, Inc.
K220882	2022-07-22	IYN	Traditional	Ge Medical Systems Ultrasound And
K221148	2022-07-18	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K221147	2022-07-18	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K220619	2022-07-15	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K220851	2022-06-27	IYN	Traditional	GE Medical Systems, LLC
K220848	2022-06-27	IYN	Traditional	GE Medical Systems, LLC
K220800	2022-06-21	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K220358	2022-06-06	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K220446	2022-05-11	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K213490	2022-04-01	MHX	Traditional	GE Medical Systems Information Technologies, Inc.
K214039	2022-03-22	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K213689	2022-02-17	IYN	Traditional	GE Healthcare GmbH
K213642	2022-01-13	IYN	Traditional	GE Healthcare GmbH
K210384	2021-11-04	CBK	Traditional	Datex-Ohmeda, Inc.
K211488	2021-09-10	IYN	Traditional	GE Healthcare GmbH
K210438	2021-09-10	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K211524	2021-08-27	IYN	Traditional	GE Healthcare GmbH
K211216	2021-06-09	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K203786	2021-04-30	DPS	Traditional	GE Medical Systems Information Technologies, Inc.
K202658	2021-03-05	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K203114	2021-01-08	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K203137	2020-12-29	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K202233	2020-11-18	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K202132	2020-11-13	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K201828	2020-10-11	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K200708	2020-09-09	IYN	Traditional	Ge Medical Systems Ultrasound And
K200851	2020-09-09	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K200743	2020-07-23	IYN	Traditional	Ge Medical Systems Ultrasound And
K200497	2020-07-16	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K200138	2020-07-01	IYN	Traditional	Ge Medical Systems Ultrasound And
K200998	2020-06-11	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K200119	2020-04-01	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K192159	2019-08-29	IYN	Traditional	GE Healthcare GmbH
K191792	2019-08-09	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K191798	2019-08-09	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K183362	2019-01-28	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K181727	2018-12-06	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K182277	2018-11-21	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K181985	2018-11-15	IYN	Traditional	GE Healthcare GmbH
K181934	2018-11-06	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K181685	2018-10-25	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K182450	2018-10-19	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K181783	2018-09-20	IYN	Traditional	GE Healthcare GmbH
K180995	2018-06-25	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K180641	2018-05-04	LLZ	Traditional	GE Healthcare GmbH
K180599	2018-05-02	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K180535	2018-03-29	IYN	Special	GE Healthcare GmbH
K180374	2018-03-13	IYN	Special	GE Healthcare GmbH
K173341	2017-11-02	IYN	Traditional	GE Medical Systems, LLC
K172342	2017-09-29	IYN	Traditional	GE Healthcare GmbH
K170714	2017-06-21	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K170878	2017-06-14	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K170823	2017-06-12	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K170445	2017-04-11	IYN	Traditional	GE Healthcare GmbH
K163596	2017-02-10	IYN	Traditional	GE Healthcare GmbH
K163077	2016-11-17	IYN	Special	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K162269	2016-10-03	IYN	Special	GE Healthcare GmbH
K161588	2016-08-31	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K161224	2016-08-05	IYN	Traditional	GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K161706	2016-08-05	IYN	Traditional	Ge Medical Systems Ultrasound and Primary Care Diagnostics L
K161047	2016-05-05	IYN	Special	GE Healthcare GmbH
K160162	2016-04-26	IYN	Traditional	GE Healthcare GmbH
K160277	2016-03-25	IYN	Traditional	GE Medical Systems Ultrasound and Primary Care Diagnostics LLC
K152814	2016-03-17	FMZ	Special	Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
K160078	2016-03-10	IYN	Traditional	Ge Medical Systems Ultrasound and Primary Care Diagnotics, L

Showing 113 of 140.

Recalls

18 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming GE Medical Systems (China) Co., Ltd.
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2026-04-21	Class II	Software Manufacturing/Software Deployment	Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.	16
2025-11-14	Class I	Component change control	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operat	888 units
2025-11-14	Class I	Component change control	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operat	1277 units
2025-11-14	Class I	Component change control	Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only operat	203 units
2025-05-16	Class II	Software design (manufacturing process)	GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could po	34 units
2025-05-16	Class II	Software design (manufacturing process)	GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could po	792 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	648 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	4036 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	217 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	4358 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	5 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	15 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	1483 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	74 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	69 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	19 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	27 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	383 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	1 unit
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	2298 units
2025-03-21	Class I	Device Design	Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilati	815 units
2023-09-08	Class II	Software design	There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.	1638 units
2018-07-24	Class II	Nonconforming Material/Component	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air functio	310 units	2020-12-16
2018-07-24	Class II	Nonconforming Material/Component	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air functio	401 units	2020-12-16
2018-07-24	Class II	Nonconforming Material/Component	On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air functio	252 units	2020-12-16
2017-10-11	Class II	Other	Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.	5,148 devices
2017-10-11	Class II	Other	Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems.	5,148 devices

PMA Approvals

A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.

FDA premarket approvals naming GE Medical Systems (China) Co., Ltd. or its listings
PMA number	Decision	Trade name	Product code	Held by
P110006	2013-06-17	SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM	PAA	GE Healthcare GmbH

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer	Device types
Wuxi Lyusmile IMP AND EXP Co., Ltd.	66
Gcmedica Enterprise Ltd.(Wuxi)	55
Emsrun Group	34
PRO-MED (Wuxi)IMP.& Exp.co., Ltd.	24
Wuxi Zontai Int’l Corporation Ltd.	22
Bioteke Corporation (Wuxi) Co., Ltd.	21
Inmed (Wuxi) Medical Device Co., Ltd.	17
Orthguide Medical Technology (Jiangsu) Co., Ltd.	17
Innovative Material & Devices, Inc.	13
Wuxi TP Orthodontics Material Co., Ltd.	9
Jiangsu Haize Medical Scientific Development Co., Ltd.	9
Visuscience Meditech Co., Ltd.	9
Wuxi Yushou Medical Appliances Co., Ltd.	8
Lincotek (Wuxi) Co., Ltd.	7
Linc Medipharm Limited	6
Wuxi Jiajian Medical Instrument Co., Ltd.	6
Wuxi EA Medical Instruments Technologies Limited	6
Jiangsu Xinbei Electrical Appliances Co., Ltd.	6
Wuxi Wemade Healthcare Products Co., Ltd.	6
Aupcon Medical Technology (Wuxi) Co., Ltd.	5
Wuxi Xindi Medical Technology Co., Ltd.	5
Goldcredit International Trading Co., Ltd.	5
Chison Medical Technologies Co., Ltd.	5
Wuxi Weigher Factory Co., Ltd.	4
Wuxi Kaishun Medical Device Manufacturing Co., Ltd.	4
Wuxi Hisky Medical Technologies Co., Ltd.	4
Wuxi FUN Gloves Co., Ltd.	3
Jiangsu Fulangte Medical Treatment Technology Co., Ltd.	3
Wuxi Phanpy Baby Products Co., Ltd.	3
Matrixed Reality Technology Co., Ltd.	3
Wuxi Wiseu IMP&EXP Co., Ltd.	3
Wuxi Biohermes BIO & Medical Technology Co., Ltd.	3
JHQ NEW Material Technology Co., Ltd.	3
Farstar (Wuxi) Medical Equipment Co., Ltd.	2
Wuxi Nest Biotechnology Co., Ltd.	2
Siemens X-RAY Vacuum Technology Ltd.	2
Biox Instruments Co Ltd	2
Broad Origin Inc.	2
Wuxi Sunmaxx Technology Co., Ltd.	2
Wuxi Medical Instrument Factory Co., Ltd.	1
Cmeos Medical SCI & Tech (Wuxi) Co., Ltd.	1
Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.	1
Wuxi Vision PRO Ltd	1
Pulnovo Medical (Wuxi) Co., Ltd.	1
Olemy Laser Technology Ltd	1
Varex Imaging Equipment (China) Co., Ltd.	1
Gaush Neotech Ltd.	1
Wuxi Guochen Medical Technology Co., Ltd.	1
Gaofeng Medical Equipment (Wuxi) Co., Ltd.	1
Jiangsu Rayer Medical Technology Co., Ltd.	1
BM Medical Technology Co., Ltd.	1
Wuxi Allied Technologies, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.