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Datex-Ohmeda Inc.

United States·US-MF-000002206

Last updated September 17, 2026

Information

Country: United States
Address: 3030, Ohmeda Drive, Madison, United States
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)345-2700
PRRC Contact: Jim Raskob
EUDAMED SRN: US-MF-000002206
FDA FEI Number: 3014220748
DUNS Number: 118933716

Catalogue (533)

Page 5 of 11

Device	Model / Reference	Registries	Class	Status
Ge Datex-Ohmeda Aisys Carestation	K042154	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Entropy Module, M-Entropy And Accessories	K023459	FDA 510(k)	Class II	Active
Datex-Ohmeda Hmef 500	K021265	FDA 510(k)	Class II	Active
S/5 Compact Critical Care Monitor With S-00c03 Or S-00c04 Software	K002158	FDA 510(k)	Class II	Active
Compatibility Ecg Trunk Cables	K043572	FDA 510(k)	Class II	Active
Datex-Ohmeda Hmef 750	K031653	FDA 510(k)	Class II	Active
Ge Datex-Ohmeda Aespire 7900 Anesthesia System	K050626	FDA 510(k)	Class II	Active
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	K251663	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Ge Datex-Ohmeda Avance Cs2	K131945	FDA 510(k)	Class II	Active
Ge Detax-Ohmeda Anesthesia Delivery Unit (adu)	K050676	FDA 510(k)	Class II	Active
Datex-Ohmeda Prestn.01 Module (model Family M-Prestn.01) And Accessories	K041772	FDA 510(k)	Class II	Active
Datex Ohmeda S/5 Network And Central (icentral) '03 With L-Net03 Software	K033281	FDA 510(k)	Class II	Active
Trip Tonometry Catheter, 14f	K993296	FDA 510(k)	Class II	Active
Datex Ohmeda S/5 Web Viewer And S/5 Pocket Viewer With L-Web03 Software	K033078	FDA 510(k)	Class II	Active
Polaris 95000-A Bedside/Transport Monitor	K031124	FDA 510(k)	Class II	Active
Datex-Ohmeda Eeg Module, M-Eeg And Datex-Ohmeda Eeg Headbox, N-Eeg And Accessories	K000892	FDA 510(k)	Class II	Active
Carescape R860	K210384	FDA 510(k)	Class II	Active
Aespire 7900, Aespire View	K122445	FDA 510(k)	Class II	Active
Giraffe Incubator Carestation CS1	K213553	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat And Accessories	K020479	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Psm Module, (consisting Of E-Psm And E-Psmp Modules) And Accessories	K043551	FDA 510(k)	Class II	Active
Trutrak Plus Enhancements To The Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories	K021955	FDA 510(k)	Class II	Active
Ge Datex-Ohmeda Aisys	K090233	FDA 510(k)	Class II	Active
Datex-Ohmeda Tuffsat 3000 Pulse Oximeter	K001688	FDA 510(k)	Class II	Active
Novii+ Wireless Patch System	K231964	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Compact Critical Care Monitor With L-Cicu02 & L-Cicu02a Software	K022740	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Anesthesia Monitor With L-An03 And L-Ane03a Software	K030812	FDA 510(k)	Class II	Active
Datex-Ohmeda Cardiocap 5, F-Mx, F-Mxg And Accessories	K992323	FDA 510(k)	Class II	Active
Datex-Ohmeda Oxy-Afr Sensor	K042891	FDA 510(k)	Class II	Active
Ge Datex-Ohmeda Heliox Delivery System	K041524	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5tm Fm With L-Ficu04 And L-Ficu04a Software And N-Fcrec Module	K043276	FDA 510(k)	Class II	Active
Datex-Ohmeda Anesthesia Vaporizer, Model D-Tec	K990132	FDA 510(k)	Class II	Active
Giraffe Omnibed Carestation CS1	K213551	FDA 510(k)	Class II	Active
Datex-Ohmeda 7900 Ventilator Enhancements	K023366	FDA 510(k)	Class II	Active
Datex-Ohmeda Ne12stpr Module (model Family M-Ne12stpr)	K993608	FDA 510(k)	Class II	Active
Datex-Ohmeda Tuffsat 3000 Pulse Oximeter	K993512	FDA 510(k)	Class II	Active
Datex-Ohmeda Tec 7 Anesthesia Vaporizer	K012924	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Anesthesia Monitor With L-Ane02 And L-Ane02a Software	K021279	FDA 510(k)	Class II	Active
Ge Datex-Ohmeda Engstrom Carestation	K051895	FDA 510(k)	Class II	Active
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2	K172045	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Critical Care Monitor With L-Icu02 And L-Icu02a Software	K021376	FDA 510(k)	Class II	Active
Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia	K000275	FDA 510(k)	Class II	Active
Carescape R860	K142679	FDA 510(k)	Class II	Active
Dates-Ohmeda Aestiva Smartvent Mri	K993410	FDA 510(k)	Class II	Active
Datex-Ohmeda Oxygen Saturation Module, M-Osat And Accessoires	K010463	FDA 510(k)	Class II	Active
Datex-Ohmeda Cs/3 Telemetry System	K000882	FDA 510(k)	Class II	Active
Datex-Ohmeda S/5 Web Viewer	K013387	FDA 510(k)	Class II	Active
Trip Tonometry Catheter, 8f	K992181	FDA 510(k)	Class II	Active
Datex-Ohmeda Trusat Pulse Oximeter And Accessories, Model 3500	K040831	FDA 510(k)	Class II	Active
Ge Datex-Ohmeda Centiva/5 Ventilator	K050860	FDA 510(k)	Class II	Active

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FDA Recalls (43)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 3, 2024	Z-0048-2025	—	open, classified	GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
Sep 3, 2024	Z-0047-2025	—	open, classified	GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
Jul 12, 2024	Z-0080-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0078-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0079-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0083-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0076-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0077-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0082-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0074-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0075-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0084-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Jul 12, 2024	Z-0081-2025	—	open, classified	Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Dec 29, 2023	Z-0774-2024	—	open, classified	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Dec 29, 2023	Z-0775-2024	—	open, classified	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Dec 29, 2023	Z-0776-2024	—	open, classified	GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstrm Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Jun 6, 2023	Z-0141-2025	—	completed	Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
Jun 6, 2023	Z-0140-2025	—	completed	Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
May 19, 2023	Z-2102-2023	—	open, classified	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
May 19, 2023	Z-2101-2023	—	open, classified	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
May 19, 2023	Z-2100-2023	—	open, classified	GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
Jun 28, 2018	Z-2738-2018	—	terminated	The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Dec 8, 2017	Z-2266-2018	—	terminated	Potential for the display processor to experience an unexpected failure.
Aug 28, 2008	Z-0020-2009	—	terminated	The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.
May 19, 2008	Z-1521-2008	—	terminated	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).
May 19, 2008	Z-1522-2008	—	terminated	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).
Jul 24, 2007	Z-0006-2008	—	terminated	Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.
Jul 2, 2007	Z-1526-2008	—	terminated	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.
Feb 2, 2007	Z-0784-2007	—	terminated	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.
Sep 15, 2006	Z-0201-2007	—	terminated	There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
Sep 11, 2006	Z-0291-2007	—	terminated	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.
Aug 17, 2006	Z-1518-2008	—	terminated	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 alarm can be heard in the control room.
Aug 17, 2006	Z-1520-2008	—	terminated	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 alarm can be heard in the control room.
Aug 17, 2006	Z-1519-2008	—	terminated	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 alarm can be heard in the control room.
Aug 10, 2006	Z-0021-2007	—	terminated	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.
Sep 27, 2005	Z-0037-06	—	terminated	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.
Sep 27, 2005	Z-0039-06	—	terminated	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.
Sep 27, 2005	Z-0038-06	—	terminated	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.
Oct 29, 2003	Z-0269-04	—	terminated	Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
Feb 12, 2003	Z-0713-03	—	terminated	Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
Feb 12, 2003	Z-0714-03	—	terminated	Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
Sep 16, 2002	Z-0610-03	—	terminated	Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.
Sep 16, 2002	Z-0611-03	—	terminated	Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Datex-Ohmeda, Inc. MADISON, WI · US FEI 2112667