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Datex-Ohmeda, Inc. FDA Recalls
28 recalls on file across devices, 21 of them Class I and 26 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000Class IIJul 30, 2026Anesthesia Delivery Systems containing certain electronic ga |
| Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000Class IIJul 30, 2026Anesthesia Delivery Systems containing certain electronic ga |
| Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000Class IIJul 30, 2026Anesthesia Delivery Systems containing certain electronic ga |
| Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic Class IIJul 30, 2026Anesthesia Delivery Systems containing certain electronic ga |
| Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826Class IMay 8, 2026Blender knob shaft can loosen, which can affect the delivere |
| Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109Class IMay 8, 2026Blender knob shaft can loosen, which can affect the delivere |
| Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) ProClass IMay 8, 2026Blender knob shaft can loosen, which can affect the delivere |
| GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubatorClass ISep 3, 2024GE HealthCare has become aware that for certain Giraffe Omni |
| GE Heathcare Giraffe OmniBed; neo natal incubatorClass ISep 3, 2024GE HealthCare has become aware that for certain Giraffe Omni |
| Amingo. OUS only.Class IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and vClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patieClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support tClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY Class IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support tClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patiClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended toClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support toClass IJul 12, 2024Potential issue that may arise if the limb of a patient brea |
| EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002Class IDec 29, 2023GE HealthCare has become aware of elevated levels of formald |
| EVair air compressor, model numbers: M1230849 and M1230847Class IDec 29, 2023GE HealthCare has become aware of elevated levels of formald |
| 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 Class IDec 29, 2023GE HealthCare has become aware of elevated levels of formald |
| GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 208Class IJun 6, 2023Prior to current established manufacturing practices, higher |
| GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828Class IJun 6, 2023Prior to current established manufacturing practices, higher |
| Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094Class IIMay 19, 2023GE HealthCare has become aware of the potential that an inco |
| Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M113582Class IIMay 19, 2023GE HealthCare has become aware of the potential that an inco |
| Beside panel FRU (Field Replacement Units) KitsClass IIMay 19, 2023GE HealthCare has become aware of the potential that an inco |