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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 2 of 11

Device	Model / Reference	Registries	Class	Status
Giraffe Blue Spot PT Lite	2063860-001	EUDAMED	Class IIa	Active
Lullaby Resus Plus – NIST	2070100-001	EUDAMED	Class IIb	Active
Giraffe Blue Spot PT Lite	M1224957	EUDAMED	Class IIa	Active
Giraffe Blue Spot PT Lite	M1238507	EUDAMED	Class IIa	Active
Aespire	View	FDA UDI	Class II	Unknown
Tec 6 Plus	VAP DES 120V USA	FDA UDI	Class II	Active
Panda EU In-Bed Scale	PS EU1	EUDAMEDFDA UDI	Class I	Active
EVair	M1230847	FDA UDI	Class II	Active
Novii	Interface 107-PT-001	FDA UDI	Class II	Active
Aisys	CS2 WITH ET CONTROL	FDA UDI	Class II	Active
BiliSoft Phototherapy System	BI2	FDA UDI	Class II	Active
Tec 7	VAP SEV 8% EASY-FIL ES LATIN AMERICA	FDA UDI	Class II	Active
Lullaby	LED Phototherapy System	EUDAMEDFDA UDI	Class II	Active
Panda	Freestanding Warmer	EUDAMEDFDA UDI	Class II	Active
Novii Interface Cable	GE FECG	FDA UDI	Class II	Active
Tec 7	VAP SEV 8% EASY-FIL EN B1	FDA UDI	Class II	Active
EVair	M1238049	FDA UDI	Class II	Active
Novii	PATCH	FDA UDI	Class II	Active
Aestiva GS	7900 3 vap art arm	FDA UDI	Class II	Unknown
Giraffe	Shuttle	EUDAMEDFDA UDI	Class II	Active
Panda	iRes Warmer	EUDAMEDFDA UDI	Class II	Active
Giraffe Panda Disposable Skin Temperature	NA	FDA UDI	Class II	Active
Rotating Iv Pole	Rotating IV1	EUDAMEDFDA UDI	Class I	Active
Panda	Wall Mount Warmer	EUDAMEDFDA UDI	Class II	Active
Well Baby Bassinet	BN2	FDA UDI	Class II	Unknown
Giraffe	Warmer	FDA UDI	Class II	Active
Aladin2	ENF EASY-FIL	FDA UDI	Class II	Active
Tec 7	VAP SEV 8% EASY-FIL EN A1	FDA UDI	Class II	Active
Giraffe Blue Spot PT Lite	BL2	EUDAMEDFDA UDI	Class II	Active
Giraffe Incubator Carestation	CS1	FDA UDI	Class II	Active
Giraffe Blue Spot PT Lite	BL1	EUDAMEDFDA UDI	Class II	Active
Tec 7	VAP SEV 8% QUIK-FIL EN	FDA UDI	Class II	Active
Well Baby Bassinet	BN5	FDA UDI	Class II	Unknown
Tec 7	VAP ISO 5% EASY-FIL ES LATIN AMERICA	FDA UDI	Class II	Active
Novii	NOVII+ POD	EUDAMEDFDA UDI	Class II	Active
Well Baby Bassinet	BN3	FDA UDI	Class II	Unknown
Aestiva	7900	FDA UDI	Class II	Unknown
Novii Interface Cable	GE UA	EUDAMEDFDA UDI	Class II	Active
Well Baby Bassinet	BN1	FDA UDI	Class II	Unknown
Novii Interface Cable	GE MECG	EUDAMEDFDA UDI	Class II	Active
Panda In-Bed Scale	PS1	EUDAMEDFDA UDI	Class I	Active
Tec 7	VAP ISO 5% EASY-FIL EN	FDA UDI	Class II	Active
Novii	POD 107-PT-003	FDA UDI	Class II	Active
Well Baby Bassinet	BN6	FDA UDI	Class II	Unknown
Giraffe Stand-alone Infant Resuscitation System	Bag and Mask	EUDAMEDFDA UDI	Class II	Active
Well Baby Bassinet	BN9	FDA UDI	Class II	Unknown
Iv Pole Assy 12 In	12 Inch IV1	EUDAMEDFDA UDI	Class I	Active
Tec 6 Plus	VAP DES 120V ES	FDA UDI	Class II	Active
Giraffe Stand-alone Infant Resuscitation System	T-piece	EUDAMEDFDA UDI	Class II	Active
Tec 7	VAP HAL 5% EASY-FIL ES LATIN AMERICA	FDA UDI	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