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GE Medical Systems Ultrasound & Primary Care Diagnostics LLC: FDA-registered device maker in Madison, WI, United States, 7 510(k) clearances

Name: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC is registered with the FDA (registration 2183066) in Madison, WI, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 20, 2026. 20 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2183066
Address: 3030 Ohmeda Drive, Madison, WI, United States, 53718
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Specification developer
First device listed: October 6, 1999
Registered through: 2027
Brand names listed: 40782, 43318, 45645, 5855555, APOLLON, Aria, Aria X-Ray Bone Densitometer, Artemis and more

Devices it lists

Device	Product code	Class	Role	Source
Assembly, Tube Housing, X-Ray, Diagnostic	ITY	1	Specification developer	accessdata.fda.gov
Collimator, Automatic, Radiographic	IZW	2	Specification developer	accessdata.fda.gov
Densitometer, Bone	KGI	2	Specification developer	accessdata.fda.gov
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 20, 2026	K252718	Lunar Astra	KGI	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
September 19, 2019	K191112	GEHC DXA Bone Densitometers with enCORE version 18	KGI	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
April 20, 2018	K180782	Aria	KGI	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
December 2, 2016	K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	KGI	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	accessdata.fda.gov
May 15, 2014	K133664	ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS	KGI	Substantially Equivalent	Ge Medical Systems Ultrasound & Primary Care Diagn	accessdata.fda.gov
October 20, 2005	K052581	LUNAR IDXA	KGI	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia	accessdata.fda.gov
August 18, 1998	K982267	DPX-RX BONE DENSITOMETER	KGI	Substantially Equivalent	Lunar Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 28, 2018	80458	Class II	Terminated	The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanica	The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.	accessdata.fda.gov
March 16, 2018	79710	Class II	Terminated	GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be comp	Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.	accessdata.fda.gov
December 8, 2017	80173	Class II	Terminated	CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg an	Potential for the display processor to experience an unexpected failure.	accessdata.fda.gov
May 19, 2008	49538	Not yet classified	Terminated	GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System)	GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).	accessdata.fda.gov
July 24, 2007	38484	Not yet classified	Terminated	GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.	Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.	accessdata.fda.gov
July 2, 2007	44927	Not yet classified	Terminated	GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA Intended to provide mechanical ventilation for adults and pediatrics weigh	Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.	accessdata.fda.gov
February 2, 2007	37105	Not yet classified	Terminated	GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Display Unit with SW version 3.x and 4.11; identification numbers 1505-9000-000 and M1057699 (upgrade). Datex-Ohmeda, Inc., a General	There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.	accessdata.fda.gov
September 15, 2006	36189	Not yet classified	Terminated	Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.	There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.	accessdata.fda.gov
September 11, 2006	36326	Not yet classified	Terminated	Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.	Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.	accessdata.fda.gov
August 17, 2006	48977	Not yet classified	Terminated	GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular a	User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alar	accessdata.fda.gov
August 10, 2006	36057	Not yet classified	Terminated	GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company	Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.	accessdata.fda.gov
March 22, 2006	34631	Not yet classified	Terminated	Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis fo	There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output.	accessdata.fda.gov
November 16, 2005	34050	Not yet classified	Terminated	Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)	Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatme	accessdata.fda.gov
September 27, 2005	33678	Not yet classified	Terminated	Datex-Ohmeda S/5 Aespire Anesthesia System 7100	Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.	accessdata.fda.gov
April 16, 2004	28936	Not yet classified	Terminated	Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine	Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.	accessdata.fda.gov
February 3, 2004	28182	Not yet classified	Terminated	Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, wi	Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.	accessdata.fda.gov
October 17, 2003	27599	Not yet classified	Terminated	Datex-Ohmeda Cardiocap/5 Patient Monitors	Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.	accessdata.fda.gov
July 15, 2003	26765	Not yet classified	Terminated	Datex-Ohmeda S/5 Anesthesia Delivery Units	Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.	accessdata.fda.gov
February 12, 2003	25632	Not yet classified	Terminated	Multi Absorbers, reference number 8003138	Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.	accessdata.fda.gov
September 16, 2002	25501	Not yet classified	Terminated	Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)	Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.	accessdata.fda.gov

Compare with other makers

Updated April 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.