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Datex-Ohmeda Inc

47 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitato recall (Z-2357-2026)Datex-Ohmeda Inc2026-06-18
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated R recall (Z-2358-2026)Datex-Ohmeda Inc2026-06-18
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted recall (Z-2359-2026)Datex-Ohmeda Inc2026-06-18
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant war recall (Z-0140-2025)DATEX--OHMEDA, INC.2024-10-31
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 20828 recall (Z-0141-2025)DATEX--OHMEDA, INC.2024-10-31
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesi recall (Z-0074-2025)Datex-Ohmeda, Inc.2024-10-18
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthe recall (Z-0075-2025)Datex-Ohmeda, Inc.2024-10-18
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesth recall (Z-0076-2025)Datex-Ohmeda, Inc.2024-10-18
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesth recall (Z-0077-2025)Datex-Ohmeda, Inc.2024-10-18
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia a recall (Z-0078-2025)Datex-Ohmeda, Inc.2024-10-18
Amingo. OUS only. recall (Z-0079-2025)Datex-Ohmeda, Inc.2024-10-18
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide gener recall (Z-0080-2025)Datex-Ohmeda, Inc.2024-10-18
Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia an recall (Z-0081-2025)Datex-Ohmeda, Inc.2024-10-18
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesi recall (Z-0082-2025)Datex-Ohmeda, Inc.2024-10-18
Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inha recall (Z-0083-2025)Datex-Ohmeda, Inc.2024-10-18
Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV K recall (Z-0084-2025)Datex-Ohmeda, Inc.2024-10-18
GE Heathcare Giraffe OmniBed; neo natal incubator recall (Z-0047-2025)DATEX--OHMEDA, INC.2024-10-17
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubato recall (Z-0048-2025)DATEX--OHMEDA, INC.2024-10-17
EVair air compressor, model numbers: M1230849 and M1230847 recall (Z-0774-2024)Datex-Ohmeda, Inc.2024-01-30
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 recall (Z-0775-2024)Datex-Ohmeda, Inc.2024-01-30
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEM recall (Z-0776-2024)Datex-Ohmeda, Inc.2024-01-30
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, recall (Z-2100-2023)DATEX--OHMEDA, INC.2023-07-06
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003 recall (Z-2101-2023)DATEX--OHMEDA, INC.2023-07-06
Beside panel FRU (Field Replacement Units) Kits recall (Z-2102-2023)DATEX--OHMEDA, INC.2023-07-06
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 recall (Z-2266-2018)Datex-Ohmeda, Inc.2018-06-01
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as G recall (Z-0020-2009)Datex - Ohmeda, Inc2008-10-06
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Va recall (Z-1518-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging s recall (Z-1519-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography sys recall (Z-1520-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System) recall (Z-1521-2008)Datex - Ohmeda, Inc2008-09-30
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System recall (Z-1522-2008)Datex - Ohmeda, Inc2008-09-30
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, G recall (Z-1526-2008)Datex - Ohmeda, Inc2008-08-16
GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aes recall (Z-0006-2008)Datex - Ohmeda, Inc2007-10-04
GE Healthcare Engstrom Carestation Critical Care Ventilator with the High Performance Disp recall (Z-0784-2007)Datex - Ohmeda, Inc2007-05-10
Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 42700200 recall (Z-0291-2007)Datex - Ohmeda, Inc2006-12-19
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers recall (Z-0201-2007)Datex - Ohmeda, Inc2006-11-21
GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE He recall (Z-0021-2007)Datex - Ohmeda, Inc2006-11-07
Datex-Ohmeda S/5 Aespire Anesthesia System 7100 recall (Z-0037-06)Datex-Ohmeda Inc2005-10-12
Datex-Ohmeda S/5 Aespire Anesthesia System 7900 recall (Z-0038-06)Datex-Ohmeda Inc2005-10-12
Datex-Ohmeda Aespire Carestation. This device is not marketed in the US. recall (Z-0039-06)Datex-Ohmeda Inc2005-10-12
Datex-Ohmeda Cardiocap/5 Patient Monitors recall (Z-0143-04)Datex-Ohmeda Inc2004-07-20
Spacelabs flat panel monitor, Model 91415-A recall (Z-0269-04)Datex-Ohmeda, Inc.2004-07-20
Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of recall (Z-0545-04)Datex-Ohmeda Inc2004-07-20
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on recall (Z-0967-04)Datex-Ohmeda Inc2004-07-20
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, o recall (Z-0968-04)Datex-Ohmeda Inc2004-07-20
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with recall (Z-0969-04)Datex-Ohmeda Inc2004-07-20
Datex-Ohmeda S/5 Anesthesia Delivery Units recall (Z-0937-03)Datex-Ohmeda Inc2003-08-28

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Every clearance here is in the API, with alerts when new ones post.