Datex-Ohmeda Inc
Datex-Ohmeda Inc appears in FDA public data with 23 recalls — including 17 Class I (most serious) —, 99 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3192-2026, Class II) was initiated on July 30, 2026. Its most recent 510(k) clearance was granted on July 28, 2026.
Summary
- Total Recalls
- 23 (17 Class I)
- 510(k) Clearances
- 99
- Inspections
- 6
- Compliance Actions
- 0
Known Names
datex-ohmeda, datex--ohmeda
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3192-2026 | Class II | Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal ox | July 30, 2026 |
| Z-3189-2026 | Class II | Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 | July 30, 2026 |
| Z-3190-2026 | Class II | Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 | July 30, 2026 |
| Z-3191-2026 | Class II | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000 | July 30, 2026 |
| Z-2357-2026 | Class I | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc | May 8, 2026 |
| Z-2359-2026 | Class I | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if | May 8, 2026 |
| Z-2358-2026 | Class I | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitati | May 8, 2026 |
| Z-0083-2025 | Class I | Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation ane | July 12, 2024 |
| Z-0084-2025 | Class I | Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO | July 12, 2024 |
| Z-0077-2025 | Class I | Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and v | July 12, 2024 |
| Z-0079-2025 | Class I | Amingo. OUS only. | July 12, 2024 |
| Z-0074-2025 | Class I | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas mach | July 12, 2024 |
| Z-0081-2025 | Class I | Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat | July 12, 2024 |
| Z-0075-2025 | Class I | Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ve | July 12, 2024 |
| Z-0082-2025 | Class I | Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and vent | July 12, 2024 |
| Z-0080-2025 | Class I | Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalat | July 12, 2024 |
| Z-0076-2025 | Class I | Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and v | July 12, 2024 |
| Z-0078-2025 | Class I | Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventila | July 12, 2024 |
| Z-0776-2024 | Class I | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-1 | December 29, 2023 |
| Z-0775-2024 | Class I | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 | December 29, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | July 28, 2026 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | October 22, 2025 |
| K213867 | Carestation 750/750c | March 28, 2023 |
| K210384 | CARESCAPE R860 | November 4, 2021 |
| K172702 | Tec 820, Tec 850 | January 4, 2018 |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 79 | November 3, 2017 |
| K170872 | Aisys CS2 | August 15, 2017 |
| K151570 | Carestation 620/650/650C | January 21, 2016 |
| K142679 | CARESCAPE R860 | June 12, 2015 |
| K143530 | Aespire View | April 24, 2015 |
| K140575 | ENGSTROM CARESTATION, ENGSTROM PRO | February 3, 2015 |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | December 20, 2013 |
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | August 8, 2013 |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | February 6, 2013 |
| K122445 | AESPIRE 7900, AESPIRE VIEW | October 12, 2012 |
| K112722 | GE DATEX-OHMEDA AVANCE | December 16, 2011 |
| K111116 | ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000 | September 9, 2011 |
| K110213 | GE DATEX-OHMEDA AISYS | July 20, 2011 |
| K090233 | GE DATEX-OHMEDA AISYS | March 5, 2009 |
| K081842 | ENGSTROM CARESTATION, ENGSTROM PRO | October 3, 2008 |