Datex-Ohmeda, Inc.

Medical device manufacturer in Waukesha, WI.

103510(k) clearances
0PMA approvals
42recalls

Device types

510(k) clearances

510(k)DeviceDecision
K254036Novii+ Wireless Patch SystemHGM · Traditional 08/10/2026SE
K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZ · Traditional 07/28/2026SE
K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional 10/22/2025SE
K231964Novii+ Wireless Patch SystemHGM · Traditional 12/08/2023SE
K213867Carestation 750/750cBSZ · Traditional 03/28/2023SE
K213553Giraffe Incubator Carestation CS1FMZ · Traditional 03/02/2022SE
K213551Giraffe Omnibed Carestation CS1FMT · Traditional 03/02/2022SE
K210384Carescape R860CBK · Traditional 11/04/2021SE
K172702Tec 820, Tec 850CAD · Traditional 01/04/2018SE
K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional 11/03/2017SE
K170872Aisys CS2BSZ · Traditional 08/15/2017SE
K151570Carestation 620/650/650CBSZ · Traditional 01/21/2016SE
K142679Carescape R860CBK · Traditional 06/12/2015SE
K143530Aespire ViewBSZ · Traditional 04/24/2015SE
K140575Engstrom Carestation, Engstrom ProCBK · Traditional 02/03/2015SE
K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)BSZ · Traditional 12/20/2013SE
K131945GE Datex-Ohmeda Avance CS2BSZ · Special 08/08/2013SE
K123125GE Datex-Ohmeda Avance CS2BSZ · Special 02/06/2013SE
K122445Aespire 7900, Aespire ViewBSZ · Special 10/12/2012SE
K112722GE Datex-Ohmeda AvanceBSZ · Traditional 12/16/2011SE
K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000CBK · Traditional 09/09/2011SE
K110213GE Datex-Ohmeda AisysBSZ · Traditional 07/20/2011SE
K090233GE Datex-Ohmeda AisysBSZ · Special 03/05/2009SE
K081842Engstrom Carestation, Engstrom ProCBK · Traditional 10/03/2008SE
K081844GE Datex-Ohmeda AvanceBSZ · Special 08/29/2008SE
K073707GE Datex-Ohmeda AisysBSZ · Special 01/30/2008SE
K072512Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible…FMZ · Special 10/03/2007SE
K071142GE Datex-Ohmeda Avance Anesthesia SystemBSZ · Special 06/06/2007SE
K062710GE Datex-Ohmeda Engstrom CarestationCBK · Traditional 12/08/2006SE
K061609GE Datex-Ohmeda AisysBSZ · Special 06/27/2006SE
K060862GE Datex-Ohmeda Engstrom CarestationCBK · Traditional 06/05/2006SE
K051895GE Datex-Ohmeda Engstrom CarestationCBK · Special 09/27/2005SE
K042891Datex-Ohmeda Oxy-Afr SensorNLF · Traditional 06/29/2005SE
K050860GE Datex-Ohmeda CENTIVA/5 VentilatorCBK · Traditional 06/21/2005SE
K050676GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)BSZ · Special 04/12/2005SE
K050626GE Datex-Ohmeda Aespire 7900 Anesthesia SystemBSZ · Special 03/25/2005SE
K050597GE Datex-Ohmeda Engstrom CarestationCBK · Special 03/25/2005SE
K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterCAH · Traditional 03/01/2005SE
K043572Compatibility ECG Trunk CablesDSA · Traditional 02/22/2005SE
K043551Datex-Ohmeda S/5 PSM Module, (Consisting of E-Psm and E-Psmp Modules) and AccessoriesMHX · Traditional 02/18/2005SE
K050055GE Datex-Ohmeda AESTIVA/5 MRI Anesthesia SystemBSZ · Special 02/04/2005SE
K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleMHX · Traditional 12/23/2004SE
K041775GE Datex-Ohmeda Engstrom CarestationCBK · Traditional 10/26/2004SE
K042771GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3MSX · Special 10/15/2004SE
K041524GE Datex-Ohmeda Heliox Delivery SystemCBK · Traditional 09/20/2004SE
K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500DPZ · Traditional 09/02/2004SE
K042154GE Datex-Ohmeda Aisys CarestationBSZ · Special 08/31/2004SE
K041772Datex-Ohmeda PRESTN.01 Module (Model Family M-PRESTN.01) and AccessoriesMHX · Special 07/28/2004SE
K041790Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A SoftwareMHX · Traditional 07/23/2004SE
K040743Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemBSZ · Special 04/22/2004SE
K032803Datex-Ohmeda S/5 Avance Anesthesia SystemBSZ · Traditional 03/10/2004SE
K031124Polaris 95000-A Bedside/Transport MonitorMHX · Traditional 12/04/2003SE
K033281Datex Ohmeda S/5 Network and Central (Icentral) '03 with L-NET03 SoftwareMSX · Traditional 11/26/2003SE
K033078Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 SoftwareMSX · Special 10/29/2003SE
K023366Datex-Ohmeda 7900 Ventilator EnhancementsCBK · Traditional 10/07/2003SE
K031027Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special 06/26/2003SE
K031781Datex-Ohmeda Prestn Module, (Model Family M-Prestn) and AccessoriesMHX · Special 06/25/2003SE
K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorCAH · Traditional 06/25/2003SE
K031653Datex-Ohmeda Hmef 750CAH · Special 06/20/2003SE
K031479Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506DXN · Special 06/06/2003SE
K030812Datex-Ohmeda S/5 Anesthesia Monitor with L-AN03 and L-ANE03A SoftwareMHX · Traditional 05/21/2003SE
K023454Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesCCK · Abbreviated 04/23/2003SE
K023459Datex-Ohmeda S/5 Entropy Module, M-Entropy and AccessoriesOLW · Traditional 01/13/2003SE
K023641Datex-Ohmeda Hmef MiniCAH · Special 11/27/2002SE
K022740Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A SoftwareMLD · Traditional 11/14/2002SE
K023497Datex-Ohmeda S/5 Web Viewer with L-6WV02 SoftwareMSX · Special 11/04/2002SE
K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters &…DQA · Special 10/08/2002SE
K022485Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE02 and L-CANE02A SoftwareMHX · Traditional 10/03/2002SE
K021265Datex-Ohmeda Hmef 500CAH · Traditional 08/30/2002SE
K022507Datex-Ohmeda S/5 Network and Central '02MSX · Special 08/23/2002SE
K021376Datex-Ohmeda S/5 Critical Care Monitor with L-ICU02 and L-ICU02A SoftwareDSI · Traditional 07/24/2002SE
K021279Datex-Ohmeda S/5 Anesthesia Monitor with L-ANE02 and L-ANE02A SoftwareMHX · Traditional 07/19/2002SE
K020479Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and AccessoriesDQA · Special 03/26/2002SE
K012924Datex-Ohmeda Tec 7 Anesthesia VaporizerCAD · Special 01/30/2002SE
K013389Datex-Ohmeda S/5 Bis Module, M-Bis and AccessoriesOLW · Traditional 01/10/2002SE
K013387Datex-Ohmeda S/5 Web ViewerMSX · Traditional 01/08/2002SE
K013246Datex-Ohmeda S/5 Network and Central '01MSX · Traditional 12/11/2001SE
K012531Datex-Ohmeda S/5 Device Interfacing Solution, N-DisxxxxMSX · Traditional 11/02/2001SE
K012837Modification to: Datex-Ohmeda Cardiocap 5 (Rev B) and AccessoriesMLD · Special 09/14/2001SE
K011670Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion…DQA · Special 06/26/2001SE
K010463Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDQA · Special 03/15/2001SE
K002478S/5 Compact Anesthesia Monitor with S-00A05, S-00A06. L-00A07, L00A08MHX · Traditional 10/05/2000SE
K002878Datex-Ohmeda D-Tec Plus Anesthesia VaporizerCAD · Special 09/21/2000SE
K002158S/5 Compact Critical Care Monitor with S-00C03 or S-00C04 SoftwareMHX · Traditional 09/06/2000SE
K001814Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and AccessoriesCCK · Abbreviated 08/23/2000SE
K000647Datex-Ohmeda Network and CentralMSX · Traditional 07/13/2000SE
K001688Datex-Ohmeda Tuffsat 3000 Pulse OximeterDQA · Special 06/30/2000SE
K000892Datex-Ohmeda EEG Module, M-Eeg and Datex-Ohmeda EEG Headbox, N-Eeg and AccessoriesOLT · Traditional 06/16/2000SE
K000815AS/3 Anesthesia Montior with S-ANE99(A)/L-ARK99(A)MHX · Traditional 06/08/2000SE
K000882Datex-Ohmeda CS/3 Telemetry SystemMHX · Traditional 06/05/2000SE
K000706Datex-Ohmeda AESTIVA/5 with 7100 VentilatorBSZ · Special 05/11/2000SE
K993410Dates-Ohmeda Aestiva Smartvent MRIBSZ · Traditional 04/25/2000SE
K993608Datex-Ohmeda NE12STPR Module (Model Family M-NE12STPR)MHX · Traditional 04/13/2000SE
K000168CS/3 Critical Care Monitor with S-ICU99(A)MHX · Traditional 04/13/2000SE
K000275Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant…CAD · Special 04/12/2000SE
K993512Datex-Ohmeda Tuffsat 3000 Pulse OximeterDQA · Special 03/31/2000SE
K993656Datex-Ohmeda Tonometry Module M-TonoCCK · Traditional 03/15/2000SE
K000186Datex-Ohmeda Inovent Delivery SystemMRN · Special 02/10/2000SE
K993296Trip Tonometry Catheter, 14FKNT · Traditional 12/15/1999SE
K992323Datex-Ohmeda Cardiocap 5, F-Mx, F-Mxg and AccessoriesMLD · Traditional 11/01/1999SE
K992181Trip Tonometry Catheter, 8FKNT · Traditional 08/24/1999SE
K990132Datex-Ohmeda Anesthesia Vaporizer, Model D-TecCAD · Special 01/21/1999SE
K983684Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse OximetersDQA · Special 11/06/1998SE

Recalls

RecallProductInitiated
Z-3192-2026 Et Control, Software option for anesthesia gas machine to achieve and maintain targeted…Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… 07/30/2026Open, Classified
Z-3191-2026 Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… 07/30/2026Open, Classified
Z-3190-2026 Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… 07/30/2026Open, Classified
Z-3189-2026 Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… 07/30/2026Open, Classified
Z-2359-2026 Class IPanda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… 05/08/2026Open, Classified
Z-2358-2026 Class IGiraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… 05/08/2026Open, Classified
Z-2357-2026 Class IGiraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… 05/08/2026Open, Classified
Z-0048-2025 Class IGE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal…GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the… 09/03/2024Open, Classified
Z-0047-2025 Class IGE Heathcare Giraffe OmniBed; neo natal incubatorGE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the… 09/03/2024Open, Classified
Z-0084-2025 Class IAuxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0083-2025 Class IAisys CS2 with Et Control. This anesthesia gas machine is intended to provide general…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0082-2025 Class IAisys CS2. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0081-2025 Class IAisys. This anesthesia gas machine is intended to provide general inhalation anesthesia…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0080-2025 Class IAvance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0079-2025 Class IAmingo. OUS only.Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0078-2025 Class IAvance. This anesthesia gas machine is intended to provide general inhalation anesthesia…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0077-2025 Class IAespire View. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0076-2025 Class IAespire 7900. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0075-2025 Class IAespire 100. This anesthesia gas machine is intended to provide general inhalation…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0074-2025 Class IAespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These…Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the… 07/12/2024Open, Classified
Z-0776-2024 Class IEvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b)…GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… 12/29/2023Open, Classified
Z-0775-2024 Class IEVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… 12/29/2023Open, Classified
Z-0774-2024 Class IEVair air compressor, model numbers: M1230849 and M1230847GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… 12/29/2023Open, Classified
Z-0141-2025 Class IGE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from… 06/06/2023Completed
Z-0140-2025 Class IGE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant…Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from… 06/06/2023Completed
Z-2102-2023 Class IIBeside panel FRU (Field Replacement Units) KitsGE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… 05/19/2023Open, Classified
Z-2101-2023 Class IIGiraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901…GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… 05/19/2023Open, Classified
Z-2100-2023 Class IIGiraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b.…GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… 05/19/2023Open, Classified
Z-2738-2018 Class IIThe Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION…The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. 06/28/2018Terminated
Z-2266-2018 Class IICARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE…Potential for the display processor to experience an unexpected failure. 12/08/2017Terminated
Z-0020-2009 GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as…The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components:… 08/28/2008Terminated
Z-1522-2008 GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging SystemGE Healthcare has become aware of a potential condition that may impact operator or patient safety. One… 05/19/2008Terminated
Z-1521-2008 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… 05/19/2008Terminated
Z-0006-2008 GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance…Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber… 07/24/2007Terminated
Z-1526-2008 GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00…Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result… 07/02/2007Terminated
Z-0784-2007 GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance…There are two unique conditions with the Engstrom Carestation that require corrective action. These include… 02/02/2007Terminated
Z-0201-2007 Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which…There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6… 09/15/2006Terminated
Z-0291-2007 Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF…Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured… 09/11/2006Terminated
Z-1520-2008 GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography…User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC… 08/17/2006Terminated
Z-1519-2008 GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging…User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC… 08/17/2006Terminated
Z-1518-2008 GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and…User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC… 08/17/2006Terminated
Z-0021-2007 GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE…Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface… 08/10/2006Terminated