Company · US
Datex-Ohmeda, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
103510(k) clearances (2 in 12 months)
56recalls (7 in 12 months)
46recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 45 |
| CBK | Ventilator, Continuous, Facility Use | 17 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 16 |
| FMZ | Incubator, Neonatal | 11 |
| MSX | System, Network And Communication, Physiological Monitors | 9 |
| DQA | Oximeter | 8 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 7 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 |
| BSF | Absorber, Carbon-Dioxide | 3 |
| BTI | Compressor, Air, Portable | 3 |
| CBN | Apparatus, Gas-Scavenging | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 |
| FMT | Warmer, Infant Radiant | 3 |
| MLD | Monitor, St Segment With Alarm | 3 |
| DPZ | Oximeter, Ear | 2 |
| HGM | System, Monitoring, Perinatal | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| OLW | Index-Generating Electroencephalograph Software | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K254036 | Novii+ Wireless Patch System Datex Ohmeda, Inc. | HGM |
| Jul 28, 2026 | K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) Datex-Ohmeda, Inc. | FMZ |
| Oct 22, 2025 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) Datex-Ohmeda, Inc. | FMZ |
| Dec 8, 2023 | K231964 | Novii+ Wireless Patch System Datex Ohmeda | HGM |
| Mar 28, 2023 | K213867 | Carestation 750/750c Datex-Ohmeda, Inc. | BSZ |
| Mar 2, 2022 | K213553 | Giraffe Incubator Carestation CS1 Datex Ohmeda, Inc. | FMZ |
| Mar 2, 2022 | K213551 | Giraffe Omnibed Carestation CS1 Datex Ohmeda, Inc. | FMT |
| Nov 4, 2021 | K210384 | CARESCAPE R860 Datex-Ohmeda, Inc. | CBK |
| Jan 4, 2018 | K172702 | Tec 820, Tec 850 Datex-Ohmeda, Inc. | CAD |
| Nov 3, 2017 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Av Datex-Ohmeda, Inc. | BSZ |
| Aug 15, 2017 | K170872 | Aisys CS2 Datex-Ohmeda, Inc. | BSZ |
| Jan 21, 2016 | K151570 | Carestation 620/650/650C Datex-Ohmeda, Inc. | BSZ |
| Jun 12, 2015 | K142679 | CARESCAPE R860 Datex-Ohmeda, Inc. | CBK |
| Apr 24, 2015 | K143530 | Aespire View Datex-Ohmeda, Inc. | BSZ |
| Feb 3, 2015 | K140575 | ENGSTROM CARESTATION, ENGSTROM PRO Datex-Ohmeda, Inc. | CBK |
| Dec 20, 2013 | K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) Datex-Ohmeda, Inc. | BSZ |
| Aug 8, 2013 | K131945 | GE DATEX-OHMEDA AVANCE CS2 Datex-Ohmeda | BSZ |
| Feb 6, 2013 | K123125 | GE DATEX-OHMEDA AVANCE CS2 Datex-Ohmeda, Inc. | BSZ |
| Oct 12, 2012 | K122445 | AESPIRE 7900, AESPIRE VIEW Datex-Ohmeda | BSZ |
| Dec 16, 2011 | K112722 | GE DATEX-OHMEDA AVANCE Datex-Ohmeda, Inc. | BSZ |
| Sep 9, 2011 | K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 Datex-Ohmeda | CBK |
| Jul 20, 2011 | K110213 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc. | BSZ |
| Mar 5, 2009 | K090233 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc. | BSZ |
| Oct 3, 2008 | K081842 | ENGSTROM CARESTATION, ENGSTROM PRO Datex-Ohmeda, Inc. | CBK |
| Aug 29, 2008 | K081844 | GE DATEX-OHMEDA AVANCE Datex-Ohmeda, Inc. | BSZ |
| Jan 30, 2008 | K073707 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc. | BSZ |
| Oct 3, 2007 | K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) Datex-Ohmeda, Inc. | FMZ |
| Jun 6, 2007 | K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM Datex-Ohmeda | BSZ |
| Dec 8, 2006 | K062710 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Jun 27, 2006 | K061609 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc. | BSZ |
| Jun 5, 2006 | K060862 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Sep 27, 2005 | K051895 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Jun 29, 2005 | K042891 | DATEX-OHMEDA OXY-AFR SENSOR Datex-Ohmeda | NLF |
| Jun 21, 2005 | K050860 | GE DATEX-OHMEDA CENTIVA/5 VENTILATOR Datex-Ohmeda, Inc. | CBK |
| Apr 12, 2005 | K050676 | GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) Datex-Ohmeda, Inc. | BSZ |
| Mar 25, 2005 | K050626 | GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM Datex-Ohmeda, Inc. | BSZ |
| Mar 25, 2005 | K050597 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Mar 1, 2005 | K043120 | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER Datex-Ohmeda, Inc. | CAH |
| Feb 22, 2005 | K043572 | COMPATIBILITY ECG TRUNK CABLES Datex-Ohmeda | DSA |
| Feb 18, 2005 | K043551 | DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES Datex-Ohmeda | MHX |
| Feb 4, 2005 | K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM Datex-Ohmeda, Inc. | BSZ |
| Dec 23, 2004 | K043276 | DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE Datex-Ohmeda | MHX |
| Oct 26, 2004 | K041775 | GE DATEX-OHMEDA ENGSTROM CARESTATION Datex-Ohmeda, Inc. | CBK |
| Oct 15, 2004 | K042771 | GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 Datex-Ohmeda | MSX |
| Sep 20, 2004 | K041524 | GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM Datex-Ohmeda, Inc. | CBK |
| Sep 2, 2004 | K040831 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Datex-Ohmeda, Inc. | DPZ |
| Aug 31, 2004 | K042154 | GE DATEX-OHMEDA AISYS CARESTATION Datex-Ohmeda, Inc. | BSZ |
| Jul 28, 2004 | K041772 | DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES Datex-Ohmeda | MHX |
| Jul 23, 2004 | K041790 | DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE Datex-Ohmeda | MHX |
| Apr 22, 2004 | K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM Datex-Ohmeda, Inc. | BSZ |
Newest 50 of 103.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Datex-Ohmeda, Inc. Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Open, Classified |
BSZ | K172045 |
| Sep 16, 2026 | Datex-Ohmeda, Inc. Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Open, Classified |
BSZ | K172045 |
| Jun 18, 2026 | Datex-Ohmeda Inc Panda Freestanding Warmer, Infant Radiant Warmer
Product Identifiers: 2063568-001
Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance. Open, Classified |
FMT | K123309 |
| Jun 18, 2026 | Datex-Ohmeda Inc Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with
Integrated Resuscitation System (iRes)
Product Identifiers: M1118179, M1112198
Impacted only if service blender M1091607- Open, Classified |
FMT | K201628 |
| Jun 18, 2026 | Datex-Ohmeda Inc Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator)
Product identifiers: 2082663-001, 2082663-002, M1241424
Product impacted only if service blender M1091607- Open, Classified |
BTM | K070247 |
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers:
1) 2082844-002-01040417;
2) 2082844-002-01044956;
3) 2082844-002-01058424;
4) 2082844-002-01069017;
5) 2082844-0 Completed |
FMZ | K152809 K213553 |
| Oct 31, 2024 | DATEX--OHMEDA, INC. GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
1) 2082844-001-01040418;
2) 2082844-001-01046784;
3) 2082844-001-01052324;
4) 208284 Completed |
FMZ | K152814 K213551 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained Open, Classified |
QSF | None listed |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified i Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in th Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Amingo. OUS only. Open, Classified |
N/A | None listed |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in t Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified Open, Classified |
BSZ | K172045 |
| Oct 18, 2024 | Datex-Ohmeda, Inc. Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and a Open, Classified |
BSZ | K172045 |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator Open, Classified |
FMZ | K152814 K213551 |
| Oct 17, 2024 | DATEX--OHMEDA, INC. GE Heathcare Giraffe OmniBed; neo natal incubator Open, Classified |
FMZ | K020543 K101788 |
| Jan 30, 2024 | Datex-Ohmeda, Inc. EvAir CPRSR Kit Upgrade:
a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847;
c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849;
d) NIST/B Open, Classified |
BTI | None listed |
| Jan 30, 2024 | Datex-Ohmeda, Inc. EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 Open, Classified |
BTI | None listed |
| Jan 30, 2024 | Datex-Ohmeda, Inc. EVair air compressor, model numbers: M1230849 and M1230847 Open, Classified |
BTI | None listed |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Beside panel FRU (Field Replacement Units) Kits Open, Classified |
FMZ | None listed |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901 Open, Classified |
FMZ | K020543 K101788 |
| Jul 6, 2023 | DATEX--OHMEDA, INC. Giraffe OmniBed Carestation CS1,
Model Numbers:
a. 2082844-001-XXX,
b. 2074920-001-XXXXXX,
c. M1050205,
d. M1135822,
e. M1145475,
f. M1145476,
g. M1235957,
h. M1149051,
i. M1146098;
Labe Open, Classified |
FMZ | K152814 K213551 |
| Jun 28, 2018 | Datex-Ohmeda, Inc. 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 designe Terminated |
CBK | K142679 |
| Jun 1, 2018 | Datex-Ohmeda, Inc. 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 patient Terminated |
CBK | K142679 |
| Oct 6, 2008 | Datex - Ohmeda, Inc GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550
Datex-Ohmeda Aisys
Intended to provide ge Terminated |
BSZ | K073707 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System Terminated |
MQB | K023178 K031637 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) Terminated |
MQB | K031637 K042053 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | K050489 K052157 +1 |
| Sep 30, 2008 | Datex - Ohmeda, Inc GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascu Terminated |
MQB | K050489 K052157 +1 |
| Sep 30, 2008 | Datex - Ohmeda, Inc 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 a Terminated |
MQB | K050489 K052157 +1 |
| Aug 16, 2008 | Datex - Ohmeda, Inc 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 adul Terminated |
CBK | K062710 |
| Oct 4, 2007 | Datex - Ohmeda, Inc 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. Terminated |
BSF | None listed |
| May 10, 2007 | Datex - Ohmeda, Inc 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-Ohm Terminated |
CBK | K060862 |
| Dec 19, 2006 | Datex - Ohmeda, Inc 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, Finlan Terminated |
BSZ | K973985 |
| Nov 21, 2006 | Datex - Ohmeda, Inc Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane. Terminated |
CAD | K000275 |
| Nov 7, 2006 | Datex - Ohmeda, Inc GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company Terminated |
BSZ | K061609 |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. Terminated |
BSZ | None listed |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Aespire Anesthesia System 7900 Terminated |
BSZ | K050626 |
| Oct 12, 2005 | Datex-Ohmeda Inc Datex-Ohmeda S/5 Aespire Anesthesia System 7100 Terminated |
BSZ | K000706 |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite. Terminated |
CBN | K993410 |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine. Terminated |
CBN | K000706 |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine Terminated |
CBN | K973896 |
| Jul 20, 2004 | Datex-Ohmeda Inc 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 Terminated |
BSZ | K973985 |
| Jul 20, 2004 | Datex-Ohmeda Inc Datex-Ohmeda Cardiocap/5 Patient Monitors Terminated |
MHX | K012837 K992323 |
Newest 50 of 56.